Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode (ECLIPSE)

April 26, 2024 updated by: Guardant Health, Inc.

The ECLIPSE (Evaluation of the ctDNA LUNAR test in an Average Patient Screening Episode) study is a prospective, observational multi-site study without randomization. The primary objective of the study is to evaluate the performance characteristics of a blood-based ctDNA LUNAR-2 test to detect colorectal cancer in a screen-relevant, average risk population.

Study Overview

Status

Active, not recruiting

Conditions

Colorectal Cancer

Detailed Description

The LUNAR-2 test has been developed to detect malignant disease in screen-relevant patients who would otherwise undergo screening for malignant disease using invasive methodologies such as colonoscopy. The intended use of such a test would be to return a result of ctDNA detected/ ctDNA not detected in a patient eligible for average risk screening for colorectal cancer. Those patients who receive a ctDNA detected result should undergo further investigation with colonoscopy.

In order to define the performance characteristics of the test in a relevant population, this study will perform a blood draw prior to the patient undergoing the standard of care colonoscopy (and all associated preparatory medications) and retrospectively compare the performance characteristics of the LUNAR-2 test with the findings of the index colonoscopy.

Outcomes of patients at one and two-years post-procedure will be collected as secondary endpoints to investigate the possibility of incidental, non-colorectal cancer cases and interval cancers that had not reached the clinical threshold for detection at the time of the index colonoscopy.

Study Type

Observational

Enrollment (Actual)

44467

Contacts and Locations

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

Study Locations

United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Pinnacle Research Group, LLC
  - Guntersville, Alabama, United States, 35976
    - Lakeview Clinical Research
  - Huntsville, Alabama, United States, 35801
    - Medical Affiliated Research Center
  - Jasper, Alabama, United States, 35501
    - Jasper Summit Research LLC
- Arizona
  - Chandler, Arizona, United States, 85224
    - Hope Research Institute
  - Chandler, Arizona, United States, 85224
    - Southeast Valley Gastroenterology
  - Gilbert, Arizona, United States, 85296
    - Prime Medical Group, LLC
  - Glendale, Arizona, United States, 85308
    - Hope Research Institute
  - Phoenix, Arizona, United States, 85037
    - GI Research Associates, LLC
  - Phoenix, Arizona, United States, 85051
    - "Forty-Third Medical Associates Absolute Clinical Research"
  - Tucson, Arizona, United States, 85741
    - Novak Clinical Research
  - Tucson, Arizona, United States, 85715
    - Del Sol Research Management, LLC
- Arkansas
  - Little Rock, Arkansas, United States, 72211
    - Preferred Research Partners, Inc
  - Little Rock, Arkansas, United States, 72211
    - Premier Gastroenterology
  - North Little Rock, Arkansas, United States, 72117
    - Arkansas Gastroenterology
- California
  - Anaheim, California, United States, 92801
    - Associated Gastroenterology Medical Group
  - Arcadia, California, United States, 91006
    - InSite Digestive Health Care
  - Burlingame, California, United States, 94010
    - Gastroenterology
  - Camarillo, California, United States, 93012
    - Ventura County Gastroenterology Medical Group
  - Canoga Park, California, United States, 91303
    - Hope Clinical Research
  - Canoga Park, California, United States, 91304
    - Alliance Research Institute
  - Chula Vista, California, United States, 91910
    - Precision Research Institute
  - Chula Vista, California, United States, 91910
    - Gastro SB Clinic
  - Encinitas, California, United States, 92024
    - Diagnamics, Inc
  - Encinitas, California, United States, 92024
    - BG Clinical Research and affiliate of The Clinical Trials Network, LLC
  - Fullerton, California, United States, 92831
    - Helping Hands Healthcare Group
  - Garden Grove, California, United States, 92840
    - Paragon Rx Clinical, Inc.
  - Huntington Beach, California, United States, 92647
    - Digestive Health Research of Southern California
  - Irvine, California, United States, 92618
    - United Medical Doctors
  - Lancaster, California, United States, 93534
    - Gastro Care Institute
  - Los Angeles, California, United States, 90033
    - University of Southern California
  - Los Angeles, California, United States, 90004
    - LA Gastroenterology Group
  - Los Angeles, California, United States, 90048
    - Gastroenterology Associates of Beverly Hills
  - Orange, California, United States, 92868
    - Knowledge Research Center
  - Oxnard, California, United States, 93030
    - InSite Digestive Health Care-San Gabriel
  - Palm Springs, California, United States, 92262
    - Desert Oasis Healthcare Medical Group
  - Palm Springs, California, United States, 92262
    - Palm Tree Clinical, Inc
  - Pasadena, California, United States, 91105
    - InSite Digestive Health Care - Gastroenterology Associates
  - Sacramento, California, United States, 95821
    - Northern California Research
  - San Diego, California, United States, 92123
    - Medical Associates Research Group
  - San Diego, California, United States, 92114
    - Precision Research Institute
  - San Diego, California, United States, 92103
    - San Diego Gastroenterology Medical Associates
  - San Diego, California, United States, 92103
    - SDG Clinical Research, Inc.
  - Thousand Oaks, California, United States, 91360
    - FOMAT Simoni AGI Medical
  - Toluca Lake, California, United States, 91602
    - Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc
  - Walnut Creek, California, United States, 94598
    - Clinical Research of California
  - Walnut Creek, California, United States, 91789
    - Curebase
- Connecticut
  - Bridgeport, Connecticut, United States, 06606
    - Gastroenterology Associates of Fairfield County
  - Hamden, Connecticut, United States, 06517
    - CMR of Greater New Haven, LLC
  - New Haven, Connecticut, United States, 06519
    - Yale University
- Florida
  - Aventura, Florida, United States, 33180
    - Innovative Medical Research of South Florida, Inc.
  - Boynton Beach, Florida, United States, 33472
    - Reciomed Clinical Research Network, Inc.
  - Coral Gables, Florida, United States, 33134
    - Clinical Research of South Florida, an AMR Company
  - Doral, Florida, United States, 33172
    - Dolphin Medical Research
  - Gainesville, Florida, United States, 32610
    - University of Florida College of Medicine
  - Hialeah, Florida, United States, 33016
    - Palmetto Research, LLC
  - Hollywood, Florida, United States, 33021
    - The Center for Gastrointestinal Disorders
  - Hollywood, Florida, United States, 33024
    - Research Centers of America
  - Jupiter, Florida, United States, 33458
    - Jupiter Medical Center
  - Jupiter, Florida, United States, 33458
    - Health Awareness, Inc
  - Lake City, Florida, United States, 32055
    - Multi-Specialty Research Associates
  - Lake Mary, Florida, United States, 32746
    - University Clinical Research-DeLand, LLC dba Accel Research Sites
  - Lakewood Ranch, Florida, United States, 34211
    - Florida Research Institute
  - Melbourne, Florida, United States, 32901
    - University Clinical Research-DeLand, LLC dba Accel Research Sites
  - Miami Lakes, Florida, United States, 33014
    - Crystal Biomedical Research
  - Ocala, Florida, United States, 34474
    - Sarkis Clinical Trials
  - Ocala, Florida, United States, 34471
    - Ocala GI Research, LLC
  - Orange City, Florida, United States, 32763
    - Gastroenterology of Greater Orlando
  - Orlando, Florida, United States, 32807
    - Gastroenterology Institute of Orlando
  - Palm Harbor, Florida, United States, 34684
    - Advanced Gastroenterology Associates, LLC
  - Sunrise, Florida, United States, 33351
    - Precision Clinical Research, LLC
  - Tampa, Florida, United States, 33614
    - Guardian Angel Research Center, LLC
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University School of Medicine
  - Atlanta, Georgia, United States, 30309
    - Digestive Health Care of Georgia
  - Atlanta, Georgia, United States, 30342
    - Metro Atlanta Gastroenterology, LLC.
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Institute
  - Evans, Georgia, United States, 30809
    - Gastroenterology Consultants of Augusta
  - Lawrenceville, Georgia, United States, 30044
    - SKY Clinical Research Network Group
  - Riverdale, Georgia, United States, 30274
    - Infinite Clinical Trials
  - Sandy Springs, Georgia, United States, 30328
    - WR-Mount Vernon Clinical Research, LLC
  - Union City, Georgia, United States, 30291
    - Rolphe Adult and Pediatric Medicine
- Illinois
  - Champaign, Illinois, United States, 61822
    - Christie Clinic
  - Chicago, Illinois, United States, 60654
    - University of Chicago Medicine
  - Chicago, Illinois, United States, 60656
    - Curebase
  - Downers Grove, Illinois, United States, 60515
    - Digestive Health Services
  - Hines, Illinois, United States, 60141
    - Edward Hines Jr. VA Hospital
  - Lake Barrington, Illinois, United States, 60010
    - Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research
  - Naperville, Illinois, United States, 60540
    - Suburban Gastroenterology Ltd
  - Northbrook, Illinois, United States, 60062
    - Comprehensive Gastrointestinal Health
  - Oak Lawn, Illinois, United States, 60453
    - DM Clinical Research
  - Rockford, Illinois, United States, 61107
    - Rockford Gastroenterology Associates, Ltd.
- Indiana
  - South Bend, Indiana, United States, 46635
    - Digestive Research Alliance of Michiana
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
- Kansas
  - El Dorado, Kansas, United States, 67042
    - Alliance for Multispecialty Research, LLC
  - Shawnee Mission, Kansas, United States, 66217
    - West Glen Gastrointestinal Consultants, P.A.
  - Wichita, Kansas, United States, 67226
    - Kansas Gastroenterology, LLC
  - Wichita, Kansas, United States, 67205
    - Alliance for Multispecialty Research-Wichita West
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Tri-State Gastroenterology Associates
  - Louisville, Kentucky, United States, 40206
    - Robley Rex VA Medical Center
  - Louisville, Kentucky, United States, 40202
    - University of Louisville Research Foundation
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Northlake Gastroenterology Associates
  - Hammond, Louisiana, United States, 70403
    - Northlake Gastroenterology Associates
  - Houma, Louisiana, United States, 70360
    - CroNOLA LLC
  - Lafayette, Louisiana, United States, 70503
    - Gastroclinic
  - Lake Charles, Louisiana, United States, 70601
    - Clinical Trials of SWLA, LLC
  - Monroe, Louisiana, United States, 71201
    - Delta Research Partners
  - Shreveport, Louisiana, United States, 71105
    - Louisiana Research Center, LLC
- Maryland
  - Columbia, Maryland, United States, 21045
    - Gastro Center of Maryland
  - Elkridge, Maryland, United States, 21075
    - Centennial Medical Group
  - Frederick, Maryland, United States, 21701
    - Frederick Gastroenterology Associates
  - Greenbelt, Maryland, United States, 20770
    - Mid-Atlantic GI Research
  - Rockville, Maryland, United States, 20854
    - Meridian Clinical Research
- Massachusetts
  - Chelmsford, Massachusetts, United States, 01824
    - Digestive Health Specialists
  - South Weymouth, Massachusetts, United States, 02190
    - South Suburban Gastroenterology
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan
  - Rochester Hills, Michigan, United States, 48307
    - Onyx Clinical Research
  - Saginaw, Michigan, United States, 48602
    - Covenant HealthCare
  - Southfield, Michigan, United States, 48034
    - Revive Research Institute, LLC
  - Troy, Michigan, United States, 48098
    - Clinical Research Institute of Michigan, LLC
- Minnesota
  - Eagan, Minnesota, United States, 55122
    - Curebase
- Mississippi
  - Columbus, Mississippi, United States, 39705
    - Gastroenterology Associates of Mississippi
  - Jackson, Mississippi, United States, 39216
    - Southern Therapy and Advanced Research
  - Ridgeland, Mississippi, United States, 39157
    - Quinn Healthcare
- Missouri
  - Chesterfield, Missouri, United States, 63005
    - Clinical Research Professionals, LLC
  - Saint Joseph, Missouri, United States, 64057
    - Digestive Health Specialists, LLC
  - Saint Louis, Missouri, United States, 63141
    - Sundance Clinical Research
  - Saint Louis, Missouri, United States, 63104
    - Saint Louis University GI & Hepatology Research Unit
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine Gastroenterology
- Nebraska
  - Elkhorn, Nebraska, United States, 68022
    - Skyline Medical Center, PC/CCT Research
  - Omaha, Nebraska, United States, 68130
    - Midwest Regional Health Services, LLC/CCT Research
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Excel Clinical Research
  - Las Vegas, Nevada, United States, 89148
    - Wr-Crcn, Llc
  - Reno, Nevada, United States, 89511
    - Advanced Research Institute
  - Reno, Nevada, United States, 89502
    - Gastroenterology Consultants
  - Reno, Nevada, United States, 89521
    - Gastroenterology Consultants
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - Hassman Research Institute
  - Brick, New Jersey, United States, 08724
    - Allied Health Clinical Research Organization, LLC
  - Clifton, New Jersey, United States, 07013
    - Gastroenterology Associates Of New Jersey
  - Florham Park, New Jersey, United States, 07932
    - AIG Digestive Disease Research
  - Freehold, New Jersey, United States, 07728
    - Allied Health Clinical Research Organization, LLC
  - Hackensack, New Jersey, United States, 07601
    - Hackensack Digestive Disease Associates
  - Hillsborough, New Jersey, United States, 08844
    - Digestive Healthcare Center
  - Jackson, New Jersey, United States, 08527
    - Allied Health Clinical Research Organization
  - Montclair, New Jersey, United States, 07042
    - Gastroenterology Associates Of New Jersey
  - Ocean City, New Jersey, United States, 07712
    - Dr. Howard N. Guss and Dr. Gagan Beri
  - Ridgewood, New Jersey, United States, 07450
    - Gastroenterology Associates Of New Jersey
  - Teaneck, New Jersey, United States, 07666
    - Teaneck Gastroenterology Associates
  - Union, New Jersey, United States, 07083
    - Advanced Gastroenterology Group
  - Wayne, New Jersey, United States, 07470
    - Gastroenterology Associates Of New Jersey
  - Wayne, New Jersey, United States, 07470
    - North Jersey Gastroenterology
  - Woodland Park, New Jersey, United States, 07424
    - Gastroenterology Associates Of New Jersey
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Lovelace Scientific Resources, Inc.
- New York
  - Brooklyn, New York, United States, 11235
    - NY Scientific
  - Brooklyn, New York, United States, 11234
    - Sam Moskowitz, MD
  - Camillus, New York, United States, 13031
    - Associated Gastroenterologists of Central New York, Camillus
  - East Syracuse, New York, United States, 13057
    - Associated Gastroenterology of Central New York
  - Fayetteville, New York, United States, 13066
    - Associated Gastroenterologists of Central New York
  - Fresh Meadows, New York, United States, 11366
    - Intercity Gastroenterology
  - Lawrence, New York, United States, 11559
    - South Island Gastro
  - Manorville, New York, United States, 11949
    - East End Gastroenterology & Hepatology
  - New City, New York, United States, 10956
    - Gastrointestinal Associates of Rockland
  - Richmond Hill, New York, United States, 11419
    - Smart Medical Research
  - Syracuse, New York, United States, 13210
    - Syracuse Gastro Associates
  - Utica, New York, United States, 13502
    - Digestive Disease Medicine of Central New York
  - Valley Stream, New York, United States, 11581
    - GastroCare LI
  - Wantagh, New York, United States, 11793
    - Gastrointestinal Specs Lng Is
  - West Nyack, New York, United States, 10994
    - Eric L. Tatar, MD
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Digestive Health Partners
  - Cary, North Carolina, United States, 27518
    - Cary Gastro Associates
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Division of Gastroenterology and Hepatology
  - Charlotte, North Carolina, United States, 28215
    - Carolinas Research Center
  - Charlotte, North Carolina, United States, 28207
    - Charlotte Gastroenterology & Hepatology, PLLC
  - Charlotte, North Carolina, United States, 28210
    - Javara Research
  - Charlotte, North Carolina, United States, 28210
    - Carolina Digestive Health Associates, PA
  - Concord, North Carolina, United States, 28027
    - Northeast GI Research Division
  - Concord, North Carolina, United States, 28025
    - Carolina Digestive Health Associates, PA
  - Fayetteville, North Carolina, United States, 28304
    - Coastal Research Institute, LLC
  - Greensboro, North Carolina, United States, 27408
    - Medication Management LLC
  - Pinehurst, North Carolina, United States, 28374
    - Pinehurst Medical Clinic
  - Raleigh, North Carolina, United States, 27609
    - PMG Research of Raleigh
  - Raleigh, North Carolina, United States, 27607
    - Carolina's GI Research, LLC
  - Rocky Mount, North Carolina, United States, 27804
    - Boice Willis Clinic, PA
  - Salisbury, North Carolina, United States, 28144
    - PMG Research of Salisbury, LLC
  - Statesville, North Carolina, United States, 28625
    - Piedmont HealthCare, PA
  - Wilmington, North Carolina, United States, 28403
    - Trial Management Associates, LLC
  - Wilmington, North Carolina, United States, 28401
    - Wilmington Health
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Plains Clinical Research Center, LLC
  - Fargo, North Dakota, United States, 58104
    - Lillestol Research, LLC
- Ohio
  - Beachwood, Ohio, United States, 44122
    - Gastroenterology Associates of Cleveland
  - Beavercreek, Ohio, United States, 45440
    - Dayton Gastroenterology, Inc.
  - Beavercreek, Ohio, United States, 45440
    - Dayton Gastroenterology
  - Cincinnati, Ohio, United States, 45267
    - University of Cincinnati
  - Cincinnati, Ohio, United States, 45219
    - Gastro Health Research
  - Columbus, Ohio, United States, 43213
    - ClinOhio Research Services
  - Dayton, Ohio, United States, 45432
    - META Medical Research Institute
  - Dayton, Ohio, United States, 45417
    - Advance Clinical Research
  - Mentor, Ohio, United States, 44060
    - Great Lakes Gastroenterology
  - Springboro, Ohio, United States, 45066
    - DSI Research, LLC
  - Toledo, Ohio, United States, 43606
    - University of Toledo Internal Medicine Clinic
  - Warren, Ohio, United States, 44484
    - Avamar Gastroenterology and Center
  - Westlake, Ohio, United States, 44145
    - Northshore Gastroenterology & Endoscopy Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists, Inc
  - Tulsa, Oklahoma, United States, 74104
    - Options Health Research, LLC
- Oregon
  - Portland, Oregon, United States, 97219
    - Fanno Creek Group
  - Portland, Oregon, United States, 97220
    - The Oregon Clinic - Gastroenterology East
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18104
    - Eastern Pennsylvania GI & Liver Specialists
  - Altoona, Pennsylvania, United States, 16602
    - US Digestive Health at Blair
  - Beaver Falls, Pennsylvania, United States, 15010
    - Valley Gastroenterology Associates
  - Camp Hill, Pennsylvania, United States, 17011
    - Susquehanna Research Group, LLC
  - Harrisburg, Pennsylvania, United States, 17110
    - Susquehanna Research Group
  - Philadelphia, Pennsylvania, United States, 19104
    - Perelman Center for Advanced Medicine
  - Philadelphia, Pennsylvania, United States, 19141
    - Einstein Medical Center Department of Digestive Disease and Transplantation
  - Uniontown, Pennsylvania, United States, 15401
    - Frontier Clinical Research, LLC
- Rhode Island
  - Cranston, Rhode Island, United States, 02920
    - GIMED Associates, Inc.
  - Narragansett, Rhode Island, United States, 02882
    - GIMED Associates, Inc.
- South Carolina
  - Greenwood, South Carolina, United States, 29646
    - Digestive Disease Research Center
  - Mount Pleasant, South Carolina, United States, 29464
    - Coastal Carolina Research Center
  - North Charleston, South Carolina, United States, 29406
    - Southeast Medical Research/Elms Research
  - Orangeburg, South Carolina, United States, 29118
    - South Carolina Clinical Research LLC
  - Summerville, South Carolina, United States, 29486
    - PPCP Division of Gastroenterology LLC
  - West Columbia, South Carolina, United States, 29169
    - Invocare Medical Research & Healthcare Center
- Tennessee
  - Austin, Tennessee, United States, 78738
    - Elligo Clinical Research Center
  - Chattanooga, Tennessee, United States, 37421
    - WR-ClinSearch, LLC
  - Chattanooga, Tennessee, United States, 37403
    - Erlanger Health Clinical Resarch
  - Germantown, Tennessee, United States, 38138
    - Gastro One
  - Jackson, Tennessee, United States, 38305
    - The Jackson Clinic
  - Jackson, Tennessee, United States, 38305
    - The Jackson Clinic, PA
  - Jackson, Tennessee, United States, 38305
    - Helios Clinical Research lLC
  - Johnson City, Tennessee, United States, 37604
    - East Tennessee Research Institute
  - Kingsport, Tennessee, United States, 37663
    - Tri-Cities Gastroenterology
  - Knoxville, Tennessee, United States, 37909
    - Gastrointestinal Associates, P.C.
  - Nashville, Tennessee, United States, 37212
    - Vanderbilt University Medical Center
  - Union City, Tennessee, United States, 38261
    - Advanced Gastroenterology
- Texas
  - Cypress, Texas, United States, 77429
    - Allied Digestive Disease Center
  - Cypress, Texas, United States, 77429
    - Northside Gastroenterology Associates
  - Cypress, Texas, United States, 77429
    - Uma Mohan MD PA
  - El Paso, Texas, United States, 79912
    - El Paso Integrated Physicians Group, P.A.
  - Houston, Texas, United States, 77030
    - University of Texas MD Anderson Cancer Center
  - Houston, Texas, United States, 77074
    - Houston Digestive Diseases Consultants
  - Houston, Texas, United States, 77024
    - Digestive Health Associates
  - Houston, Texas, United States, 77055
    - Biopharma Informatic
  - Houston, Texas, United States, 77057
    - Diversified Medical Practices
  - Houston, Texas, United States, 77084
    - Memorial Hermann Surgery Center
  - Hurst, Texas, United States, 76054
    - Protenium Clinical Research Inc.
  - McAllen, Texas, United States, 78503
    - Biopharma Informatic
  - Pasadena, Texas, United States, 77504
    - Gastroenterology Consultants, P.A.
  - San Antonio, Texas, United States, 78212
    - Clinical Associates in Research Therapeutics of America
  - Shenandoah, Texas, United States, 77384
    - Gastroenterology Partners of North Houston
  - Spring, Texas, United States, 77386
    - Texas Gastroenterology Associates/A1 Clinical Network
  - Sugar Land, Texas, United States, 77479
    - Gastroenterology Associates of Texas, PA
  - Tomball, Texas, United States, 77375
    - Texas Gastro Consultants
  - Wichita Falls, Texas, United States, 76301
    - Digestive Health Research of North Texas
- Utah
  - Bountiful, Utah, United States, 84010
    - Progressive Clinical Research
  - Ogden, Utah, United States, 84405
    - Advanced Research Institute
  - Sandy, Utah, United States, 84092
    - Advanced Research Institute Granite Peaks Gastroenterology
- Virginia
  - Charlottesville, Virginia, United States, 22911
    - Charlottesville Medical Research
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
  - Fairfax, Virginia, United States, 22031
    - Verity Research
  - Lynchburg, Virginia, United States, 24502
    - Blue Ridge Medical Research
  - Reston, Virginia, United States, 20191
    - The Gastroenterology Group
  - Richmond, Virginia, United States, 23236
    - GI Select Health Research, LLC
  - Williamsburg, Virginia, United States, 23188
    - Tidewater Physicians Multispecialty Group Clinical Research
- Washington
  - Bellevue, Washington, United States, 98004
    - Washington Gastroenterology
  - Everett, Washington, United States, 98208
    - Western Washington Medical Group, Inc
  - Spokane, Washington, United States, 99202
    - Velocity Clinical Research
- Wisconsin
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial, Inc
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Stevens Point, Wisconsin, United States, 54482
    - GI Associates
  - Wausau, Wisconsin, United States, 54401
    - GI Associates

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

45 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Single cohort of patients aged between 45 and 84, with no known high risk features, undergoing routine colorectal cancer screening as standard of care.

Description

Inclusion Criteria:

Subjects aged 45-84 years at time of consent
Intended to undergo screening colonoscopy
Considered by a physician or healthcare provider as being of 'average risk' for CRC
Willing to consent to blood draw pre-bowel preparation administration prior to undergoing colonoscopy within 60 days of the date of the investigational blood draw
Willing to consent to follow-up for two years as per protocol

Exclusion Criteria:

Undergoing colonoscopy for investigation of symptoms
Has undergone colonoscopy within preceding 9 years
Positive FIT/FOBT result within the previous 6 months
Has completed Cologuard or Epi proColon testing within the previous 3 years
History of colorectal cancer
History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
Known diagnosis of inflammatory bowel disease
Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
Positive family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age
Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC [HNPCC], or Familial Adenomatous Polyposis [FAP])
Any major physical trauma (e.g. disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent
Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of colorectal cancer detection Time Frame: 60 days	Sensitivity of colorectal cancer detection	60 days
Specificity of advanced neoplasia detection Time Frame: 60 days	Specificity of advanced neoplasia detection	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of colorectal cancer detection Time Frame: 60 days	Positive predictive value of colorectal cancer detection	60 days
Negative predictive value of colorectal cancer detection Time Frame: 60 days	Negative predictive value of colorectal cancer detection	60 days
Sensitivity and specificity of advanced adenoma detection Time Frame: 60 days	Sensitivity and specificity of advanced adenoma detection	60 days

Collaborators and Investigators

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

Sponsor

Guardant Health, Inc.

Collaborators

Premier Research Group plc

Investigators

Principal Investigator: Craig Eagle, MD, Guardant Health, Inc.

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)

October 8, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

02-GI-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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 Colorectal Cancer

University of California, San Francisco

Completed

Diet Education Program for Stage I-IV Colorectal Cancer Survivors

Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditions

United States
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)

Terminated

Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors

Rectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditions

United States
University of Southern California
National Cancer Institute (NCI)

Terminated

Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer

Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditions

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer

Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditions

United States
Wake Forest University Health Sciences
National Cancer Institute (NCI)

Completed

Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors

Cancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditions

United States
M.D. Anderson Cancer Center

Recruiting

Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study

Colorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditions

United States
City of Hope Medical Center

Recruiting

Early Onset Colorectal Cancer Detection (ENCODE)

Colorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage I

United States, Japan, Italy, Spain
University of Roma La Sapienza

Completed

Matrilysin Expression in Different Stages of Colorectal Tumors (MMP7)

Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage I

Italy
Sidney Kimmel Cancer Center at Thomas Jefferson...
United States Department of Defense

Active, not recruiting

Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

Colorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditions

United States
University of Southern California
National Cancer Institute (NCI); Amgen

Terminated

5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab

Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...

United States

Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode (ECLIPSE)

Study Overview

Status

Conditions

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Colorectal Cancer

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