LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia (LOTUS)

January 7, 2026 updated by: Richard Dunne, University of Rochester

Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia

This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC.

SECONDARY OBJECTIVES:

I. To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente.

III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cachexia symptoms, and physical function data.

EXPLORATORY OBJECTIVE:

I. To evaluate for tumor-derived factors contributing to CC by determining the association between interleukin-6 (IL-6) expression in tumor and IL-6 and CC chemokine ligand 2 (CCL2) levels in the blood in patients with CC.

OUTLINE: This is an observational study.

Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care computed tomography (CT) or positron emission tomography (PET)/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, United States, 80303
        • Active, not recruiting
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, United States, 80304
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, United States, 80112
        • Active, not recruiting
        • Rocky Mountain Cancer Centers - Centennial
      • Denver, Colorado, United States, 80209
        • Active, not recruiting
        • The Women's Imaging Center
      • Denver, Colorado, United States, 80218
        • Active, not recruiting
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80218
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Rose
      • Englewood, Colorado, United States, 80113
        • Active, not recruiting
        • Rocky Mountain Cancer Centers - Swedish
      • Englewood, Colorado, United States, 80113
        • Active, not recruiting
        • The Melanoma and Skin Cancer Institute
      • Lakewood, Colorado, United States, 80228
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80120
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, United States, 80124
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Thornton, Colorado, United States, 80260
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Thornton
    • Delaware
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Christiana Care Health System-Wilmington Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Principal Investigator:
          • Marcus S. Noel
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
        • Principal Investigator:
          • Aldemar Montero
      • Braselton, Georgia, United States, 30517
        • Recruiting
        • Northeast Georgia Medical Center Braselton
        • Contact:
        • Principal Investigator:
          • Andrew T. Johnson
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • John B Amos Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew W. Pippas
      • Duluth, Georgia, United States, 30096
        • Recruiting
        • Northside Hospital - Duluth
        • Contact:
        • Principal Investigator:
          • Aldemar Montero
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Northeast Georgia Medical Center-Gainesville
        • Contact:
        • Principal Investigator:
          • Andrew T. Johnson
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • The Longstreet Clinic - Gainesville
        • Contact:
          • Site Public Contact
          • Phone Number: 770-219-9010
        • Principal Investigator:
          • Andrew T. Johnson
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Northside Hospital - Gwinnett
        • Contact:
        • Principal Investigator:
          • Aldemar Montero
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center
        • Contact:
        • Principal Investigator:
          • William E. Burak
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
        • Contact:
        • Principal Investigator:
          • Mark A. Taylor
      • Tifton, Georgia, United States, 31794
        • Recruiting
        • Tift Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-648-1935
        • Principal Investigator:
          • Apurva N. Shah
      • Valdosta, Georgia, United States, 31602
        • Recruiting
        • South Georgia Medical Center/Pearlman Cancer Center
        • Contact:
        • Principal Investigator:
          • Samuel N. Ofori
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
        • Principal Investigator:
          • Jared D. Acoba
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Contact:
        • Principal Investigator:
          • Jared D. Acoba
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Cancer Cenrer - POB I
        • Contact:
          • Site Public Contact
          • Phone Number: 808-532-0315
        • Principal Investigator:
          • Jared D. Acoba
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-545-8548
        • Principal Investigator:
          • Jared D. Acoba
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Straub Clinic and Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 808-522-4333
        • Principal Investigator:
          • Jared D. Acoba
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Queen's Cancer Center - Kuakini
        • Contact:
          • Site Public Contact
          • Phone Number: 808-531-8521
        • Principal Investigator:
          • Jared D. Acoba
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Hawaii Cancer Care - Westridge
        • Contact:
        • Principal Investigator:
          • Jared D. Acoba
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Pali Momi Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-486-6000
        • Principal Investigator:
          • Jared D. Acoba
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Queen's Cancer Center - Pearlridge
        • Contact:
          • Site Public Contact
          • Phone Number: 808-487-7447
        • Principal Investigator:
          • Jared D. Acoba
      • ‘Ewa Beach, Hawaii, United States, 96706
        • Recruiting
        • The Queen's Medical Center - West Oahu
        • Contact:
        • Principal Investigator:
          • Jared D. Acoba
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • OSF Saint Anthony's Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Thomas J. Saphner
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Thomas J. Saphner
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Thomas J. Saphner
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Thomas J. Saphner
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle BroMenn Medical Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle Cancer Institute Normal
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Thomas J. Saphner
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Outpatient Center - Oak Lawn
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Thomas J. Saphner
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Active, not recruiting
        • Reid Health
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Randi Kihnel
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Recruiting
        • Christiana Care - Union Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Iron Mountain, Michigan, United States, 49801
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
    • Missouri
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Recruiting
        • Carson Tahoe Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Henderson
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • OptumCare Cancer Care at Seven Hills
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Urology Specialists of Nevada - Green Valley
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Urology Specialists of Nevada - Southwest
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Northwest
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • OptumCare Cancer Care at MountainView
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Urology Specialists of Nevada - Northwest
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Town Center
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Summerlin
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Central Valley
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
    • New York
      • Dansville, New York, United States, 14437
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Principal Investigator:
          • Vincent P. Vinciguerra
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Vincent P. Vinciguerra
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye Ear and Throat Hospital
        • Principal Investigator:
          • Vincent P. Vinciguerra
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Po-Ju Lin
      • Rochester, New York, United States, 14620
        • Recruiting
        • Highland Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 585-341-8113
        • Principal Investigator:
          • Po-Ju Lin
      • Rochester, New York, United States, 14606
        • Recruiting
        • Wilmot Cancer Institute Radiation Oncology at Greece
        • Contact:
          • Site Public Contact
          • Phone Number: 585-758-7877
        • Principal Investigator:
          • Po-Ju Lin
      • Rochester, New York, United States, 14623
        • Recruiting
        • Pluta Cancer Center
        • Contact:
        • Principal Investigator:
          • Po-Ju Lin
      • Webster, New York, United States, 14580
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Active, not recruiting
        • Indu and Raj Soin Medical Center
      • Belpre, Ohio, United States, 45714
        • Recruiting
        • Strecker Cancer Center-Belpre
        • Contact:
        • Principal Investigator:
          • Aruna C. Gowda
      • Boardman, Ohio, United States, 44512
        • Active, not recruiting
        • Saint Elizabeth Boardman Hospital
      • Cincinnati, Ohio, United States, 45236
        • Active, not recruiting
        • Oncology Hematology Care Inc-Kenwood
      • Dayton, Ohio, United States, 45415
        • Active, not recruiting
        • Dayton Physician LLC - Englewood
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Armes Family Cancer Center
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Blanchard Valley Hospital
      • Franklin, Ohio, United States, 45005
        • Active, not recruiting
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Active, not recruiting
        • Wayne Hospital
      • Kettering, Ohio, United States, 45409
        • Active, not recruiting
        • Greater Dayton Cancer Center
      • Kettering, Ohio, United States, 45429
        • Active, not recruiting
        • Kettering Medical Center
      • Marietta, Ohio, United States, 45750
        • Recruiting
        • Marietta Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Aruna C. Gowda
      • Troy, Ohio, United States, 45373
        • Active, not recruiting
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, United States, 44484
        • Active, not recruiting
        • Saint Joseph Warren Hospital
      • Youngstown, Ohio, United States, 44501
        • Active, not recruiting
        • Saint Elizabeth Youngstown Hospital
    • Oregon
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Nadia N. Ramdin
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Nadia N. Ramdin
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Nadia N. Ramdin
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • AnMed Health Cancer Center
        • Principal Investigator:
          • Leander Cannick
        • Contact:
      • Bluffton, South Carolina, United States, 29910
        • Recruiting
        • Saint Joseph's/Candler - Bluffton Campus
        • Contact:
        • Principal Investigator:
          • Mark A. Taylor
      • Gaffney, South Carolina, United States, 29341
        • Recruiting
        • Gibbs Cancer Center-Gaffney
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Butternut
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Hilton Head Island, South Carolina, United States, 29926-3827
        • Recruiting
        • South Carolina Cancer Specialists PC
        • Contact:
        • Principal Investigator:
          • Mark A. Taylor
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Union, South Carolina, United States, 29379
        • Recruiting
        • SMC Center for Hematology Oncology Union
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
    • Virginia
      • South Hill, Virginia, United States, 23970
        • Recruiting
        • VCU Community Memorial Health Center
        • Principal Investigator:
          • Masey M. Ross
        • Contact:
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Shenandoah Oncology PC
        • Principal Investigator:
          • Masey M. Ross
        • Contact:
    • Washington
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 360-788-8223
        • Principal Investigator:
          • Alison K. Conlin
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Julia Stoffel
      • Appleton, Wisconsin, United States, 54915
        • Recruiting
        • Ascension Saint Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Brookfield, Wisconsin, United States, 53045
        • Recruiting
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Chilton, Wisconsin, United States, 53014
        • Recruiting
        • Ascension Calumet Hospital
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Aurora Saint Luke's South Shore
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Eau Claire, Wisconsin, United States, 54701
      • Eau Claire, Wisconsin, United States, 54701
        • Suspended
        • HSHS Sacred Heart Hospital
      • Franklin, Wisconsin, United States, 53132
        • Recruiting
        • Ascension Saint Francis - Reiman Cancer Center
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:
      • Greenfield, Wisconsin, United States, 53228
        • Recruiting
        • Aurora Health Center - Greenfield
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
          • Site Public Contact
          • Phone Number: 414-302-2304
          • Email: ncorp@aah.org
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Marshfield, Wisconsin, United States, 54449
      • Mequon, Wisconsin, United States, 53097
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital Ozaukee
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Milwaukee, Wisconsin, United States, 53211
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Ascension Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Racine, Wisconsin, United States, 53405
        • Recruiting
        • Ascension All Saints Hospital
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • Rice Lake, Wisconsin, United States, 54868
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Stevens Point, Wisconsin, United States, 54482
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
        • Contact:
        • Principal Investigator:
          • Bradley C. Heraly
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, colorectal cancer.

Description

Inclusion Criteria:

  • Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer

    • Note: Patients do not need to have cachexia to be eligible

  • Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.

    • NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended > 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy [RT]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Be able to understand, speak and read English
  • Be 18 years of age or older

Exclusion Criteria:

  • Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
  • Have any planned major surgeries within the next 3 months
  • Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
  • Be pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (survey, function tests, biospecimen, actigraph)
Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
Other: Electronic Health Record Review
Medical records reviewed
Other: Survey Administration
Complete surveys
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT or PET/CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Biospecimen Collection
Undergo collection of blood and archived tumor samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Medical Device Usage and Evaluation
Wear actigraph
Other: Physical Performance Testing
Undergo physical function tests
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC)
Time Frame: Baseline through study completion, assessed up to 1 year follow up
Defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. First, will examine the distributions of each variable and assess the need for using transformations to achieve normality for continuous variables (log transformation, quartiles, or clinically important thresholds), collapsing similar variables into single categories, and excluding conditions that are too rare (< 1% of the cohort). Next, will assess statistical correlations using the Jaccard similarity metric for binary variables and the Pearson or Spearman correlation for continuous variables to determine highly correlated variables that may provide redundant information.
Baseline through study completion, assessed up to 1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of each CC phenotype (clusters) with overall survival
Time Frame: Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
Will be assessed in the Cox regression model. Will estimate the bivariate association where the only independent variables will be the indicators for the cluster membership. Will report the hazard ratio for the association of each CC phenotype, specifying the lowest-risk cluster as the reference. Will assess the influence of selected factors (e.g., age, performance status, and other known prognostic factors) on the association of the cluster with survival by adding the factor to the model as a covariate and keeping those that resulted in 10% or more change in any regression coefficients for cluster membership. Will assess if the association of clusters with survival varies by specific subgroups (e.g., older versus younger age, gender, and cancer type). Will assess the statistical significance interaction of the subgroup with the cluster membership by maximum likelihood test and evaluate the regression coefficients for clusters in each subgroup comparing the direction and magnitude.
Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente
Time Frame: Up to study completion, assessed up to 1 year
Study participants will be categorized into the Kaiser Permanente Northern California (KPNC)-derived CC phenotype groups. Will use the final latent class analysis model fit in the KPNC data to compute the posterior probabilities of membership in each latent class for each individual National Cancer Institute Community Oncology Research Program (NCORP) participant based on his/her individual data. Will compare cluster prevalence in each cohort as well as the distributions of the variables used to determine each cluster to investigate patterns of commonality and dissimilarity across the contributing variables. Validation will be determined by fitting University of Rochester Cancer Center (URCC) NCORP participants in KPNC-derived clusters and evaluating each cluster's association with survival. If the ranking of survival (best to worst) among each cluster in the URCC NCORP dataset mirrors the prognostic ranking of clusters in the KPNC dataset, the clusters will be deemed validated.
Up to study completion, assessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Richard F Dunne, University of Rochester NCORP Research Base

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

November 13, 2027

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC-22063 (Other Identifier: CTEP)
  • UG1CA189961 (U.S. NIH Grant/Contract)
  • NCI-2023-04268 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

IPD Plan Description

Currently, there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage IV Pancreatic Cancer AJCC v8

Clinical Trials on Electronic Health Record Review

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe