Family Communications After Genetic Testing

June 15, 2026 updated by: Alliance for Clinical Trials in Oncology

Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer

This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the proportion of first-degree relatives (FDRs) of probands with Lynch Syndrome who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-mediated (Arm A) at 6 months.

II. To compare the proportion of FDRs of proband with a non-Lynch pathogenic germline variant who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-mediated arm (Arm A) at 6 months.

SECONDARY OBJECTIVE:

I. To compare the proportion of FDRs with a pathogenic germline variant (PGV) who underwent disease prevention efforts at 12 months between the provider-mediated arm (Arm B) and the proband-mediated cascade testing arm (Arm A).

EXPLORATORY OBJECTIVES:

I. To assess differences in percentages of cascade genetic testing within the following proband subgroups: race/ethnicity (non-Hispanic whites; other race/ethnicities), sex (females; males), age (>= 50; < 50), tumor location (colon; rectal), tumor stage (stage I-II; stage III-IV), geographic location (urban; rural), and receipt of medical care in an academic versus (vs.) community setting.

III. To determine the prevalence and spectrum of pathogenic germline variants in cancer susceptibility genes by analysis of results of upfront germline testing in a multi-site cancer cooperative group study population with newly diagnosed CRC.

IV. Assess the pattern of accrual of demographic patient subgroups including racial/ethnic minority and rural individuals at the initial 50% of accrual enrolled and at the end of the trial.

V. To compare disease-free survival (DFS) of the proband at 3 years between the direct-contact arm (Arm B) and the proband-directed cascade testing arm (Arm A).

V. To evaluate the completion rate of a Social Determinants of Health questionnaire with patient directed questions .

OUTLINE:

STEP 1: Patients (probands) undergo collection of blood samples and genetic testing on study.

STEP 2: Probands with pathogenic or likely pathogenic germline variants and their FDRs are randomized to 1 of 2 arms.

ARM A: FDRs receive proband-mediated communication about the proband's genetic testing results.

ARM B: FDRs receive provider-mediated communication about the proband's genetic testing results.

Probands are followed for up to 3 years and FDRs are followed for up to 1 year

Study Type

Interventional

Enrollment (Estimated)

4186

Phase

  • Not Applicable

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
    • Alaska
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Fairbanks, Alaska, United States, 99701
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • 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
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • California
      • Arroyo Grande, California, United States, 93420
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Carmichael, California, United States, 95608
      • Carmichael, California, United States, 95608
      • Elk Grove, California, United States, 95758
      • Merced, California, United States, 95340
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Rocklin, California, United States, 95765
      • Sacramento, California, United States, 95816
      • San Luis Obispo, California, United States, 93401
      • Santa Maria, California, United States, 93444
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation - Santa Rosa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Santa Rosa, California, United States, 95405
        • Recruiting
        • Providence Santa Rosa Memorial Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • St. Helena, California, United States, 94574
        • Recruiting
        • Saint Helena Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 707-967-3698
        • Principal Investigator:
          • Ethan D. Schram
      • Stockton, California, United States, 95204
        • Recruiting
        • Saint Joseph's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 209-461-5257
        • Principal Investigator:
          • Shahzad Siddique
      • Woodland, California, United States, 95695
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado, United States, 80923
      • Durango, Colorado, United States, 81301
      • Durango, Colorado, United States, 81301
      • Lakewood, Colorado, United States, 80228
      • Longmont, Colorado, United States, 80501
      • Pueblo, Colorado, United States, 81004
      • Westminster, Colorado, United States, 80023
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • 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
      • 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:
      • 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
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • 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
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • SSM Health Good Samaritan
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • 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:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • 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
      • Rockford, Illinois, United States, 61108
        • Recruiting
        • OSF Saint Anthony Medical Center
        • Principal Investigator:
          • Shylendra B. Sreenivasappa
        • Contact:
          • Site Public Contact
          • Phone Number: 815-227-2633
      • 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:
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Pittsburg, Kansas, United States, 66762
        • Recruiting
        • Mercy Hospital Pittsburg
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Cancer Center / Stormont Vail Health
        • Contact:
          • Site Public Contact
          • Phone Number: 785-270-4939
        • Principal Investigator:
          • Brandon R. Weckbaugh
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Corbin, Kentucky, United States, 40701
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40504
      • Lexington, Kentucky, United States, 40504
      • London, Kentucky, United States, 40741
      • Mount Sterling, Kentucky, United States, 40353
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Principal Investigator:
          • Pallavi P. Kumar
        • Contact:
          • Site Public Contact
          • Phone Number: 410-601-9083
      • Randallstown, Maryland, United States, 21133
      • Towson, Maryland, United States, 21204
        • Recruiting
        • UM Saint Joseph Medical Center
        • Contact:
        • Principal Investigator:
          • Syed S. Nasir
      • Westminster, Maryland, United States, 21157
        • Recruiting
        • William E Kahlert Regional Cancer Center/Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 410-871-6400
        • Principal Investigator:
          • Pallavi P. Kumar
    • Michigan
      • Alma, Michigan, United States, 48801
        • Recruiting
        • MyMichigan Medical Center Gratiot
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Alpena, Michigan, United States, 49707
        • Recruiting
        • MyMichigan Medical Center Alpena
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Brighton, Michigan, United States, 48114
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Canton, Michigan, United States, 48188
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Chelsea, Michigan, United States, 48118
      • Clarkston, Michigan, United States, 48346
      • Clarkston, Michigan, United States, 48346
        • Suspended
        • Newland Medical Associates-Clarkston
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Health Saint John Hospital
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Henry Ford River District Hospital
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Cancer Hematology Centers - Flint
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Gladwin, Michigan, United States, 48624
        • Recruiting
        • MyMichigan Medical Center Gladwin
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Breast
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Academic
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Van Elslander
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Henry Ford Warren Hospital - Breast Macomb
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Henry Ford Saint John Hospital - Macomb Medical
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Midland, Michigan, United States, 48670
        • Recruiting
        • MyMichigan Medical Center Midland
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Mount Pleasant, Michigan, United States, 48858
        • Recruiting
        • MyMichigan Medical Center Mount Pleasant
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Michigan Healthcare Professionals Pontiac
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Saginaw, Michigan, United States, 48601
      • Tawas City, Michigan, United States, 48764
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Madison Heights Hospital - Breast
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Health Warren Hospital
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Warren Hospital - GLCMS
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Chaska, Minnesota, United States, 55318
        • Recruiting
        • Minnesota Oncology Hematology PA-Chaska
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Minnesota Oncology - Coon Rapids
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Minnesota Oncology - Edina
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology - Maple Grove
        • Principal Investigator:
          • Yan Ji
        • Contact:
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Mercy Oncology and Hematology - Clayton-Clarkson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Mercy Cancer Center - Cape Girardeau
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Phelps Health Delbert Day Cancer Institute
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • 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
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • 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, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • 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
      • St Louis, Missouri, United States, 63109
        • Recruiting
        • Mercy Infusion Center - Chippewa
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • 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
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Havre, Montana, United States, 59501
        • Recruiting
        • Hi-Line Sletten Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Helena, Montana, United States, 59601
        • Recruiting
        • Benefis Helena Specialty Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
      • Kearney, Nebraska, United States, 68847
      • Omaha, Nebraska, United States, 68122
      • Omaha, Nebraska, United States, 68124
      • Omaha, Nebraska, United States, 68130
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • CaroMont Regional Medical Center
        • Contact:
        • Principal Investigator:
          • James G. McGrath
      • Lincolnton, North Carolina, United States, 28092
        • Recruiting
        • CaroMont Health - Lincoln Cancer Center
        • Principal Investigator:
          • James G. McGrath
        • Contact:
          • Site Public Contact
          • Phone Number: 704-671-7031
    • Ohio
      • Alliance, Ohio, United States, 44601
        • Recruiting
        • Aultman Alliance Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 330-363-1250
        • Principal Investigator:
          • Mehool A. Patel
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Health Foundation
        • Contact:
        • Principal Investigator:
          • Mehool A. Patel
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Principal Investigator:
          • Jordan Kharofa
        • Contact:
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45247
      • Cincinnati, Ohio, United States, 45255
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Principal Investigator:
          • Jordan Kharofa
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Baker City
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Hood River, Oregon, United States, 97031
        • Recruiting
        • Providence Hood River Memorial Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • 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:
      • Redmond, Oregon, United States, 97756
        • Recruiting
        • Saint Charles Health System-Redmond
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 541-706-2909
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Recruiting
        • Pocono Medical Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Lehigh Valley Hospital-Hazleton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Rapid City Regional Hospital
        • Principal Investigator:
          • Abdel-Ghani Azzouqa
        • Contact:
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Mount Vernon, Washington, United States, 98274
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98122-5711
        • Recruiting
        • Swedish Medical Center-Cherry Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Silverdale, Washington, United States, 98383
        • Recruiting
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Cancer Care Northwest - Spokane South
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Spokane, Washington, United States, 99216
        • Recruiting
        • Cancer Care Northwest-Valley
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Spokane, Washington, United States, 99218
        • Recruiting
        • Cancer Care Northwest-North Spokane
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Wisconsin
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • Yan Ji
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Memorial Hospital of Laramie County
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:

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

Yes

Description

Inclusion Criteria:

  • STEP 1 PROBANDS: Age >= 18 years

  • STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV

    • Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into/involve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary
    • Patients with more than one primary colon adenocarcinoma are eligible
  • STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer
  • STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers
  • STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible
  • STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes
  • STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis
  • STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish

  • STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members

    * No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician

  • STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene
  • FDRs: Age >= 18 years
  • FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes
  • FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents
  • FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish

Exclusion Criteria:

-

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Step 1 (biospecimen collection, genetic testing)
Probands undergo collection of blood samples and genetic testing on study.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other: Genetic Testing
Undergo genetic testing
Active Comparator: Step 2, Arm A (proband-mediated)
FDRs receive proband-mediated communication about the proband's genetic testing results.
Other: Survey Administration
Ancillary studies
Other: Communication Intervention
Receive proband-mediated communication
Experimental: Step 2, Arm B (provider-mediated)
FDRs receive provider-mediated communication about the proband's genetic testing results.
Other: Survey Administration
Ancillary studies
Other: Communication Intervention
Receive proband-mediated communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible first-degree relatives (FDRs) of the affected proband who underwent genetic testing
Time Frame: Within 6 months of proband randomization
This is a binary outcome. To test for a between-arm difference in the proportion of eligible FDRs receiving genetic testing, the primary analysis will apply a mixed-effects logistic regression model to account for between-family variability or equivalently the within family correlation. The mixed-effects logistic regression model will be applied separately within the subset of families who are associated with a proband who has Lynch syndrome (LS), and within the subset of families who are associated with a proband who harbors non-LS pathogenic germline variants (PGVs).
Within 6 months of proband randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible FDRs with a PGV undergoing disease prevention efforts
Time Frame: Within 12 months of proband randomization
Binary outcome indicating whether an eligible FDR with a PGV who underwent disease prevention efforts at 12 months between the provider-mediated arm (Arm B) and the proband-mediated cascade testing arm (Arm A).
Within 12 months of proband randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible FDRs of the affected proband who underwent genetic testing
Time Frame: Within 6 months of proband randomization
Will repeat LS and non-LS analyses according to pre-defined proband sub-groups (Non-Hispanic White vs. other races/ethnicities; female vs. male; age >= 50 vs. < 50; urban vs. rural; academic setting vs. community setting). It is clinically important to quantify the effect of the provider-mediated direct-contact approach within these subgroups and the degree of imprecision as measured by the corresponding confidence interval. Thus, we will report the odds ratio and descriptive 95% confidence interval.
Within 6 months of proband randomization
Degree to which the somatic tumor profiling identifies a germline event
Time Frame: up to 3 years
Will estimate the proportion of cases where the germline mutation is detected by somatic next generation sequencing testing of the tumor. The corresponding lower bound of the one-sided 90% interval will be calculated for the true but unknown proportion.
up to 3 years
Spectrum and prevalence of PGVs in cancer susceptibility genes
Time Frame: Up to 3 years
For each, descriptive statistics will include the frequency and percentage as well as the standard error.
Up to 3 years
Disease-free survival (DFS) of probands
Time Frame: From the date the patient is randomized on study for first documentation of primary tumor recurrence/relapse or death, assessed up to 3 years
: DFS will be compared between direct-contact arm and proband-directed cascade testing arm. DFS percentages, standard errors, and the intervention effect comparison will be obtained from the Kaplan-Meier method, Greenwood's formula, and log-rank tests, respectively. Cox proportional hazards regression models will be used to estimate relative risks and 95% confidence intervals for the intervention comparison.
From the date the patient is randomized on study for first documentation of primary tumor recurrence/relapse or death, assessed up to 3 years
Accrual patterns
Time Frame: up to 3 years
Summary of participant accrual over time, including recruitment rates by site and arm.
up to 3 years

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Frank A Sinicrope, Alliance for Clinical Trials in Oncology

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)

April 6, 2026

Primary Completion (Estimated)

November 5, 2029

Study Completion (Estimated)

November 5, 2032

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

August 20, 2025

First Posted (Actual)

August 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A212101
  • NCI-2023-03178 (Other Identifier: NCI Clinical Trial Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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