NCT04136002

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44,467

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

271 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

4.5 years

First QC Date

October 21, 2019

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of colorectal cancer detection

    Sensitivity of colorectal cancer detection

    60 days

  • Specificity of advanced neoplasia detection

    Specificity of advanced neoplasia detection

    60 days

Secondary Outcomes (3)

  • Positive predictive value of colorectal cancer detection

    60 days

  • Negative predictive value of colorectal cancer detection

    60 days

  • Sensitivity and specificity of advanced adenoma detection

    60 days

Eligibility Criteria

Age45 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (271)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Lakeview Clinical Research

Guntersville, Alabama, 35976, United States

Location

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

Jasper Summit Research LLC

Jasper, Alabama, 35501, United States

Location

Hope Research Institute

Chandler, Arizona, 85224, United States

Location

Southeast Valley Gastroenterology

Chandler, Arizona, 85224, United States

Location

Prime Medical Group, LLC

Gilbert, Arizona, 85296, United States

Location

Hope Research Institute

Glendale, Arizona, 85308, United States

Location

GI Research Associates, LLC

Phoenix, Arizona, 85037, United States

Location

"Forty-Third Medical Associates Absolute Clinical Research"

Phoenix, Arizona, 85051, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

Novak Clinical Research

Tucson, Arizona, 85741, United States

Location

Del Sol Research Management, LLC

Tuscon, Arizona, 85715, United States

Location

Preferred Research Partners, Inc

Little Rock, Arkansas, 72211, United States

Location

Premier Gastroenterology

Little Rock, Arkansas, 72211, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Associated Gastroenterology Medical Group

Anaheim, California, 92801, United States

Location

InSite Digestive Health Care

Arcadia, California, 91006, United States

Location

Gastroenterology

Burlingame, California, 94010, United States

Location

Ventura County Gastroenterology Medical Group

Camarillo, California, 93012, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Alliance Research Institute

Canoga Park, California, 91304, United States

Location

Gastro SB Clinic

Chula Vista, California, 91910, United States

Location

Precision Research Institute

Chula Vista, California, 91910, United States

Location

BG Clinical Research and affiliate of The Clinical Trials Network, LLC

Encinitas, California, 92024, United States

Location

Diagnamics, Inc

Encinitas, California, 92024, United States

Location

Helping Hands Healthcare Group

Fullerton, California, 92831, United States

Location

Paragon RX Clinical, Inc.

Garden Grove, California, 92840, United States

Location

Digestive Health Research of Southern California

Huntington Beach, California, 92647, United States

Location

United Medical Doctors

Irvine, California, 92618, United States

Location

Gastro Care Institute

Lancaster, California, 93534, United States

Location

LA Gastroenterology Group

Los Angeles, California, 90004, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Gastroenterology Associates of Beverly Hills

Los Angeles, California, 90048, United States

Location

Knowledge Research Center

Orange, California, 92868, United States

Location

InSite Digestive Health Care-San Gabriel

Oxnard, California, 93030, United States

Location

Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

Location

Palm Tree Clinical, Inc

Palm Springs, California, 92262, United States

Location

InSite Digestive Health Care - Gastroenterology Associates

Pasadena, California, 91105, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

San Diego Gastroenterology Medical Associates

San Diego, California, 92103, United States

Location

SDG Clinical Research, Inc.

San Diego, California, 92103, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

FOMAT Simoni AGI Medical

Thousand Oaks, California, 91360, United States

Location

Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc

Toluca Lake, California, 91602, United States

Location

Curebase

Walnut Creek, California, 91789, United States

Location

Clinical Research of California

Walnut Creek, California, 94598, United States

Location

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06606, United States

Location

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Innovative Medical Research of South Florida, Inc.

Aventura, Florida, 33180, United States

Location

Reciomed Clinical Research Network, Inc.

Boynton Beach, Florida, 33472, United States

Location

Clinical Research of South Florida, an AMR Company

Coral Gables, Florida, 33134, United States

Location

Dolphin Medical Research

Doral, Florida, 33172, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Palmetto Research, LLC

Hialeah, Florida, 33016, United States

Location

The Center for Gastrointestinal Disorders

Hollywood, Florida, 33021, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Health Awareness, Inc

Jupiter, Florida, 33458, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Multi-Specialty Research Associates

Lake City, Florida, 32055, United States

Location

University Clinical Research-DeLand, LLC dba Accel Research Sites

Lake Mary, Florida, 32746, United States

Location

Florida Research Institute

Lakewood Rch, Florida, 34211, United States

Location

University Clinical Research-DeLand, LLC dba Accel Research Sites

Melbourne, Florida, 32901, United States

Location

Crystal Biomedical Research

Miami Lakes, Florida, 33014, United States

Location

Ocala GI Research, LLC

Ocala, Florida, 34471, United States

Location

Sarkis Clinical Trials

Ocala, Florida, 34474, United States

Location

Gastroenterology of Greater Orlando

Orange City, Florida, 32763, United States

Location

Gastroenterology Institute of Orlando

Orlando, Florida, 32807, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Guardian Angel Research Center, LLC

Tampa, Florida, 33614, United States

Location

Digestive Health Care of Georgia

Atlanta, Georgia, 30309, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Metro Atlanta Gastroenterology, LLC.

Atlanta, Georgia, 30342, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Gastroenterology Consultants of Augusta

Evans, Georgia, 30809, United States

Location

SKY Clinical Research Network Group

Lawrenceville, Georgia, 30044, United States

Location

Infinite Clinical Trials

Riverdale, Georgia, 30274, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Rolphe Adult and Pediatric Medicine

Union City, Georgia, 30291, United States

Location

Christie Clinic

Champaign, Illinois, 61822, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60654, United States

Location

Curebase

Chicago, Illinois, 60656, United States

Location

Digestive Health Services

Downers Grove, Illinois, 60515, United States

Location

Edward Hines Jr. VA Hospital

Hines, Illinois, 60141, United States

Location

Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research

Lake Barrington, Illinois, 60010, United States

Location

Suburban Gastroenterology Ltd

Naperville, Illinois, 60540, United States

Location

Comprehensive Gastrointestinal Health

Northbrook, Illinois, 60062, United States

Location

DM Clinical Research

Oak Lawn, Illinois, 60453, United States

Location

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107, United States

Location

Digestive Research Alliance of Michiana

South Bend, Indiana, 46635, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Alliance for Multispecialty Research, LLC

El Dorado, Kansas, 67042, United States

Location

West Glen Gastrointestinal Consultants, P.A.

Shawnee, Kansas, 66217, United States

Location

Alliance for Multispecialty Research-Wichita West

Wichita, Kansas, 67205, United States

Location

Kansas Gastroenterology, LLC

Wichita, Kansas, 67226, United States

Location

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, 41017, United States

Location

University of Louisville Research Foundation

Louisville, Kentucky, 40202, United States

Location

Robley Rex VA Medical Center

Louisville, Kentucky, 40206, United States

Location

Northlake Gastroenterology Associates

Covington, Louisiana, 70433, United States

Location

Northlake Gastroenterology Associates

Hammond, Louisiana, 70403, United States

Location

CroNola LLC

Houma, Louisiana, 70360, United States

Location

Gastroclinic

Lafayette, Louisiana, 70503, United States

Location

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, 70601, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Frederick Gastroenterology Associates

Frederick, Maryland, 21701, United States

Location

Mid-Atlantic GI Research

Greenbelt, Maryland, 20770, United States

Location

Meridian Clinical Research

Rockville, Maryland, 20854, United States

Location

Digestive Health Specialists

Chelmsford, Massachusetts, 01824, United States

Location

South Suburban Gastroenterology

South Weymouth, Massachusetts, 02190, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Onyx Clinical Research

Rochester Hills, Michigan, 48307, United States

Location

Covenant HealthCare

Saginaw, Michigan, 48602, United States

Location

Revive Research Institute, LLC

Southfield, Michigan, 48034, United States

Location

Clinical Research Institute of Michigan, LLC

Troy, Michigan, 48098, United States

Location

Curebase

Eagan, Minnesota, 55122, United States

Location

Gastroenterology Associates of Mississippi

Columbus, Mississippi, 39705, United States

Location

Southern Therapy and Advanced Research

Jackson, Mississippi, 39216, United States

Location

Quinn Healthcare

Ridgeland, Mississippi, 39157, United States

Location

Clinical Research Professionals, LLC

Chesterfield, Missouri, 63005, United States

Location

Digestive Health Specialists, LLC

Saint Joseph, Missouri, 64057, United States

Location

Saint Louis University GI & Hepatology Research Unit

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine Gastroenterology

St Louis, Missouri, 63110, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Skyline Medical Center, PC/CCT Research

Elkhorn, Nebraska, 68022, United States

Location

Midwest Regional Health Services, LLC/CCT Research

Omaha, Nebraska, 68130, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Wr-Crcn, Llc

Las Vegas, Nevada, 89148, United States

Location

Gastroenterology Consultants

Reno, Nevada, 89502, United States

Location

Advanced Research Institute

Reno, Nevada, 89511, United States

Location

Gastroenterology Consultants

Reno, Nevada, 89521, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Allied Health Clinical Research Organization, LLC

Brick, New Jersey, 08724, United States

Location

Gastroenterology Associates Of New Jersey

Clifton, New Jersey, 07013, United States

Location

AIG Digestive Disease Research

Florham Park, New Jersey, 07932, United States

Location

Allied Health Clinical Research Organization, LLC

Freehold, New Jersey, 07728, United States

Location

Hackensack Digestive Disease Associates

Hackensack, New Jersey, 07601, United States

Location

Digestive Healthcare Center

Hillsborough, New Jersey, 08844, United States

Location

Allied Health Clinical Research Organization

Jackson, New Jersey, 08527, United States

Location

Gastroenterology Associates Of New Jersey

Montclair, New Jersey, 07042, United States

Location

Dr. Howard N. Guss and Dr. Gagan Beri

Ocean City, New Jersey, 07712, United States

Location

Gastroenterology Associates Of New Jersey

Ridgewood, New Jersey, 07450, United States

Location

Teaneck Gastroenterology Associates

Teaneck, New Jersey, 07666, United States

Location

Advanced Gastroenterology Group

Union, New Jersey, 07083, United States

Location

Gastroenterology Associates Of New Jersey

Wayne, New Jersey, 07470, United States

Location

North Jersey Gastroenterology

Wayne, New Jersey, 07470, United States

Location

Gastroenterology Associates Of New Jersey

Woodland Park, New Jersey, 07424, United States

Location

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108, United States

Location

Sam Moskowitz, MD

Brooklyn, New York, 11234, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Associated Gastroenterologists of Central New York, Camillus

Camillus, New York, 13031, United States

Location

Associated Gastroenterology of Central New York

East Syracuse, New York, 13057, United States

Location

Associated Gastroenterologists of Central New York

Fayetteville, New York, 13066, United States

Location

Intercity Gastroenterology

Fresh Meadows, New York, 11366, United States

Location

South Island Gastro

Lawrence, New York, 11559, United States

Location

East End Gastroenterology & Hepatology

Manorville, New York, 11949, United States

Location

Gastrointestinal Associates of Rockland

New City, New York, 10956, United States

Location

Smart Medical Research

Richmond Hill, New York, 11419, United States

Location

Syracuse Gastro Associates

Syracuse, New York, 13210, United States

Location

Digestive Disease Medicine Of Central New York

Utica, New York, 13502, United States

Location

GastroCare LI

Valley Stream, New York, 11581, United States

Location

Gastrointestinal Specs Lng Is

Wantagh, New York, 11793, United States

Location

Eric L. Tatar, MD

West Nyack, New York, 10994, United States

Location

Digestive Health Partners

Asheville, North Carolina, 28801, United States

Location

Cary Gastro Associates

Cary, North Carolina, 27518, United States

Location

UNC Division of Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599, United States

Location

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Carolina Digestive Health Associates, PA

Charlotte, North Carolina, 28210, United States

Location

Javara Research

Charlotte, North Carolina, 28210, United States

Location

Carolinas Research Center

Charlotte, North Carolina, 28215, United States

Location

Carolina Digestive Health Associates, PA

Concord, North Carolina, 28025, United States

Location

Northeast GI Research Division

Concord, North Carolina, 28027, United States

Location

Coastal Research Institute, LLC

Fayetteville, North Carolina, 28304, United States

Location

Medication Management LLC

Greensboro, North Carolina, 27408, United States

Location

Pinehurst Medical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Carolina's GI Research, LLC

Raleigh, North Carolina, 27607, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

Boice Willis Clinic, PA

Rocky Mount, North Carolina, 27804, United States

Location

PMG Research of Salisbury, LLC

Salisbury, North Carolina, 28144, United States

Location

Piedmont HealthCare, PA

Statesville, North Carolina, 28625, United States

Location

Wilmington Health

Wilmington, North Carolina, 28401, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

PMG Research of Winston

Winston-Salem, North Carolina, 27103, United States

Location

Lillestol Research, LLC

Fargo, North Dakota, 58104, United States

Location

Plains Clinical Research Center, LLC

Fargo, North Dakota, 58104, United States

Location

Gastroenterology Associates of Cleveland

Beachwood, Ohio, 44122, United States

Location

Dayton Gastroenterology, Inc.

Beavercreek, Ohio, 45440, United States

Location

Dayton Gastroenterology

Beavercreek, Ohio, 45440, United States

Location

Gastro Health Research

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

Advance Clinical Research

Dayton, Ohio, 45417, United States

Location

META Medical Research Institute

Dayton, Ohio, 45432, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

DSI Research, LLC

Springboro, Ohio, 45066, United States

Location

University of Toledo Internal Medicine Clinic

Toledo, Ohio, 43606, United States

Location

Avamar Gastroenterology and Center

Warren, Ohio, 44484, United States

Location

Northshore Gastroenterology & Endoscopy Center

Westlake, Ohio, 44145, United States

Location

Digestive Disease Specialists, Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Fanno Creek Group

Portland, Oregon, 97219, United States

Location

The Oregon Clinic - Gastroenterology East

Portland, Oregon, 97220, United States

Location

Eastern Pennsylvania GI & Liver Specialists

Allentown, Pennsylvania, 18104, United States

Location

US Digestive Health at Blair

Altoona, Pennsylvania, 16602, United States

Location

Valley Gastroenterology Associates

Beaver Falls, Pennsylvania, 15010, United States

Location

Susquehanna Research Group, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Susquehanna Research Group

Harrisburg, Pennsylvania, 17110, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Einstein Medical Center Department of Digestive Disease and Transplantation

Philadelphia, Pennsylvania, 19141, United States

Location

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401, United States

Location

GIMED Associates, Inc.

Cranston, Rhode Island, 02920, United States

Location

GIMED Associates, Inc.

Narragansett, Rhode Island, 02882, United States

Location

Digestive Disease Research Center

Greenwood, South Carolina, 29646, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Southeast Medical Research/Elms Research

North Charleston, South Carolina, 29406, United States

Location

South Carolina Clinical Research LLC

Orangeburg, South Carolina, 29118, United States

Location

PPCP Division of Gastroenterology LLC

Summerville, South Carolina, 29486, United States

Location

Invocare Medical Research & Healthcare Center

West Columbia, South Carolina, 29169, United States

Location

Elligo Clinical Research Center

Austin, Tennessee, 78738, United States

Location

Erlanger Health Clinical Resarch

Chattanooga, Tennessee, 37403, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Helios Clinical Research lLC

Jackson, Tennessee, 38305, United States

Location

The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

East Tennessee Research Institute

Johnson City, Tennessee, 37604, United States

Location

Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663, United States

Location

Gastrointestinal Associates, P.C.

Knoxville, Tennessee, 37909, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Advanced Gastroenterology

Union City, Tennessee, 38261, United States

Location

Allied Digestive Disease Center

Cypress, Texas, 77429, United States

Location

Northside Gastroenterology Associates

Cypress, Texas, 77429, United States

Location

Uma Mohan MD PA

Cypress, Texas, 77429, United States

Location

El Paso Integrated Physicians Group, P.A.

El Paso, Texas, 79912, United States

Location

Digestive Health Associates

Houston, Texas, 77024, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Biopharma Informatic

Houston, Texas, 77055, United States

Location

Diversified Medical Practices

Houston, Texas, 77057, United States

Location

Houston Digestive Diseases Consultants

Houston, Texas, 77074, United States

Location

Memorial Hermann Surgery Center

Houston, Texas, 77084, United States

Location

Protenium Clinical Research Inc.

Hurst, Texas, 76054, United States

Location

Biopharma Informatic

McAllen, Texas, 78503, United States

Location

Gastroenterology Consultants, P.A.

Pasadena, Texas, 77504, United States

Location

Clinical Associates in Research Therapeutics of America

San Antonio, Texas, 78212, United States

Location

Gastroenterology Partners of North Houston

Shenandoah, Texas, 77384, United States

Location

Texas Gastroenterology Associates/A1 Clinical Network

Spring, Texas, 77386, United States

Location

Gastroenterology Associates of Texas, PA

Sugar Land, Texas, 77479, United States

Location

Texas Gastro Consultants

Tomball, Texas, 77375, United States

Location

Digestive Health Research of North Texas

Wichita Falls, Texas, 76301, United States

Location

Progressive Clinical Research

Bountiful, Utah, 84010, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Advanced Research Institute Granite Peaks Gastroenterology

Sandy City, Utah, 84092, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Verity Research

Fairfax, Virginia, 22031, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

The Gastroenterology Group

Reston, Virginia, 20191, United States

Location

GI Select Health Research, LLC

Richmond, Virginia, 23236, United States

Location

Tidewater Physicians Multispecialty Group Clinical Research

Williamsburg, Virginia, 23188, United States

Location

Washington Gastroenterology

Bellevue, Washington, 98004, United States

Location

Western Washington Medical Group, Inc

Everett, Washington, 98208, United States

Location

Velocity Clinical Research

Spokane, Washington, 99202, United States

Location

Holy Family Memorial, Inc

Manitowoc, Wisconsin, 54221, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

GI Associates

Stevens Point, Wisconsin, 54482, United States

Location

GI Associates

Wausau, Wisconsin, 54401, United States

Location

Related Publications (2)

  • Lo YMD. Cell-free DNA for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):1047-1050. doi: 10.1056/NEJMe2311101. No abstract available.

  • Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be retained in order to investigate the performance characteristics of the LUNAR-2 device.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Craig Eagle, MD

    Guardant Health, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

October 8, 2019

Primary Completion

March 20, 2024

Study Completion

August 5, 2025

Last Updated

August 11, 2025

Record last verified: 2025-08

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