Blood test could revolutionize colon cancer screening

NCT ID NCT04136002

Diagnosis Sponsor: Guardant Health, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new blood test called LUNAR-2 that looks for DNA from colorectal cancer in the bloodstream. It involves over 44,000 average-risk adults aged 45-84 who are already scheduled for a screening colonoscopy. The goal is to see how well this blood test can detect colorectal cancer compared to the standard colonoscopy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

44,467 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

45 to 84 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects aged 45-84 years at time of consent 2. Intended to undergo screening colonoscopy 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC 4. 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 5. Willing to consent to follow-up for two years as per protocol Exclusion Criteria: 1. Undergoing colonoscopy for investigation of symptoms 2. Has undergone colonoscopy within preceding 9 years 3. Positive FIT/FOBT result within the previous 6 months 4. Has completed Cologuard or Epi proColon testing within the previous 3 years 5. History of colorectal cancer 6. 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) 7. Known diagnosis of inflammatory bowel disease 8. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs) 9. Positive family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age 10. Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]) 11. 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 12. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study 13. 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

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

"Forty-Third Medical Associates Absolute Clinical Research"

Phoenix, Arizona, 85051, United States
AIG Digestive Disease Research

Florham Park, New Jersey, 07932, United States
Advance Clinical Research

Dayton, Ohio, 45417, United States
Advanced Gastroenterology

Union City, Tennessee, 38261, United States
Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States
Advanced Gastroenterology Group

Union, New Jersey, 07083, United States
Advanced Research Institute

Reno, Nevada, 89511, United States
Advanced Research Institute

Ogden, Utah, 84405, United States
Advanced Research Institute Granite Peaks Gastroenterology

Sandy City, Utah, 84092, United States
Alliance Research Institute

Canoga Park, California, 91304, United States
Alliance for Multispecialty Research, LLC

El Dorado, Kansas, 67042, United States
Alliance for Multispecialty Research-Wichita West

Wichita, Kansas, 67205, United States
Allied Digestive Disease Center

Cypress, Texas, 77429, United States
Allied Health Clinical Research Organization

Jackson, New Jersey, 08527, United States
Allied Health Clinical Research Organization, LLC

Brick, New Jersey, 08724, United States
Allied Health Clinical Research Organization, LLC

Freehold, New Jersey, 07728, United States
Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States
Associated Gastroenterologists of Central New York

Fayetteville, New York, 13066, United States
Associated Gastroenterologists of Central New York, Camillus

Camillus, New York, 13031, United States
Associated Gastroenterology Medical Group

Anaheim, California, 92801, United States
Associated Gastroenterology of Central New York

East Syracuse, New York, 13057, United States
Avamar Gastroenterology and Center

Warren, Ohio, 44484, United States
BG Clinical Research and affiliate of The Clinical Trials Network, LLC

Encinitas, California, 92024, United States
Biopharma Informatic

Houston, Texas, 77055, United States
Biopharma Informatic

McAllen, Texas, 78503, United States
Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States
Boice Willis Clinic, PA

Rocky Mount, North Carolina, 27804, United States
CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States
Carolina Digestive Health Associates, PA

Charlotte, North Carolina, 28210, United States
Carolina Digestive Health Associates, PA

Concord, North Carolina, 28025, United States
Carolina's GI Research, LLC

Raleigh, North Carolina, 27607, United States
Carolinas Research Center

Charlotte, North Carolina, 28215, United States
Cary Gastro Associates

Cary, North Carolina, 27518, United States
Centennial Medical Group

Elkridge, Maryland, 21075, United States
Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, 28207, United States
Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States
Christie Clinic

Champaign, Illinois, 61822, United States
ClinOhio Research Services

Columbus, Ohio, 43213, United States
Clinical Associates in Research Therapeutics of America

San Antonio, Texas, 78212, United States
Clinical Research Institute of Michigan, LLC

Troy, Michigan, 48098, United States
Clinical Research Professionals, LLC

Chesterfield, Missouri, 63005, United States
Clinical Research of California

Walnut Creek, California, 94598, United States
Clinical Research of South Florida, an AMR Company

Coral Gables, Florida, 33134, United States
Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, 70601, United States
Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States
Coastal Research Institute, LLC

Fayetteville, North Carolina, 28304, United States
Columbus Regional Research Institute

Columbus, Georgia, 31904, United States
Comprehensive Gastrointestinal Health

Northbrook, Illinois, 60062, United States
Covenant HealthCare

Saginaw, Michigan, 48602, United States
CroNola LLC

Houma, Louisiana, 70360, United States
Crystal Biomedical Research

Miami Lakes, Florida, 33014, United States
Curebase

Walnut Creek, California, 91789, United States
Curebase

Chicago, Illinois, 60656, United States
Curebase

Eagan, Minnesota, 55122, United States
DM Clinical Research

Oak Lawn, Illinois, 60453, United States
DSI Research, LLC

Springboro, Ohio, 45066, United States
Dayton Gastroenterology

Beavercreek, Ohio, 45440, United States
Dayton Gastroenterology, Inc.

Beavercreek, Ohio, 45440, United States
Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States
Del Sol Research Management, LLC

Tuscon, Arizona, 85715, United States
Delta Research Partners

Monroe, Louisiana, 71201, United States
Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States
Diagnamics, Inc

Encinitas, California, 92024, United States
Digestive Disease Medicine Of Central New York

Utica, New York, 13502, United States
Digestive Disease Research Center

Greenwood, South Carolina, 29646, United States
Digestive Disease Specialists, Inc

Oklahoma City, Oklahoma, 73112, United States
Digestive Health Associates

Houston, Texas, 77024, United States
Digestive Health Care of Georgia

Atlanta, Georgia, 30309, United States
Digestive Health Partners

Asheville, North Carolina, 28801, United States
Digestive Health Research of North Texas

Wichita Falls, Texas, 76301, United States
Digestive Health Research of Southern California

Huntington Beach, California, 92647, United States
Digestive Health Services

Downers Grove, Illinois, 60515, United States
Digestive Health Specialists

Chelmsford, Massachusetts, 01824, United States
Digestive Health Specialists, LLC

Saint Joseph, Missouri, 64057, United States
Digestive Healthcare Center

Hillsborough, New Jersey, 08844, United States
Digestive Research Alliance of Michiana

South Bend, Indiana, 46635, United States
Diversified Medical Practices

Houston, Texas, 77057, United States
Dolphin Medical Research

Doral, Florida, 33172, United States
Dr. Howard N. Guss and Dr. Gagan Beri

Ocean City, New Jersey, 07712, United States
East End Gastroenterology & Hepatology

Manorville, New York, 11949, United States
East Tennessee Research Institute

Johnson City, Tennessee, 37604, United States
Eastern Pennsylvania GI & Liver Specialists

Allentown, Pennsylvania, 18104, United States
Edward Hines Jr. VA Hospital

Hines, Illinois, 60141, United States
Einstein Medical Center Department of Digestive Disease and Transplantation

Philadelphia, Pennsylvania, 19141, United States
El Paso Integrated Physicians Group, P.A.

El Paso, Texas, 79912, United States
Elligo Clinical Research Center

Austin, Tennessee, 78738, United States
Emory University School of Medicine

Atlanta, Georgia, 30322, United States
Eric L. Tatar, MD

West Nyack, New York, 10994, United States
Erlanger Health Clinical Resarch

Chattanooga, Tennessee, 37403, United States
Excel Clinical Research

Las Vegas, Nevada, 89109, United States
FOMAT Simoni AGI Medical

Thousand Oaks, California, 91360, United States
Fanno Creek Group

Portland, Oregon, 97219, United States
Florida Research Institute

Lakewood Rch, Florida, 34211, United States
Frederick Gastroenterology Associates

Frederick, Maryland, 21701, United States
Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401, United States
GI Associates

Stevens Point, Wisconsin, 54482, United States
GI Associates

Wausau, Wisconsin, 54401, United States
GI Research Associates, LLC

Phoenix, Arizona, 85037, United States
GI Select Health Research, LLC

Richmond, Virginia, 23236, United States
GIMED Associates, Inc.

Cranston, Rhode Island, 02920, United States
GIMED Associates, Inc.

Narragansett, Rhode Island, 02882, United States
Gastro Care Institute

Lancaster, California, 93534, United States
Gastro Center of Maryland

Columbia, Maryland, 21045, United States
Gastro Health Research

Cincinnati, Ohio, 45219, United States
Gastro One

Germantown, Tennessee, 38138, United States
Gastro SB Clinic

Chula Vista, California, 91910, United States
GastroCare LI

Valley Stream, New York, 11581, United States
Gastroclinic

Lafayette, Louisiana, 70503, United States
Gastroenterology

Burlingame, California, 94010, United States
Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research

Lake Barrington, Illinois, 60010, United States
Gastroenterology Associates Of New Jersey

Clifton, New Jersey, 07013, United States
Gastroenterology Associates Of New Jersey

Montclair, New Jersey, 07042, United States
Gastroenterology Associates Of New Jersey

Ridgewood, New Jersey, 07450, United States
Gastroenterology Associates Of New Jersey

Wayne, New Jersey, 07470, United States
Gastroenterology Associates Of New Jersey

Woodland Park, New Jersey, 07424, United States
Gastroenterology Associates of Beverly Hills

Los Angeles, California, 90048, United States
Gastroenterology Associates of Cleveland

Beachwood, Ohio, 44122, United States
Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06606, United States
Gastroenterology Associates of Mississippi

Columbus, Mississippi, 39705, United States
Gastroenterology Associates of Texas, PA

Sugar Land, Texas, 77479, United States
Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States
Gastroenterology Consultants

Reno, Nevada, 89502, United States
Gastroenterology Consultants

Reno, Nevada, 89521, United States
Gastroenterology Consultants of Augusta

Evans, Georgia, 30809, United States
Gastroenterology Consultants, P.A.

Pasadena, Texas, 77504, United States
Gastroenterology Institute of Orlando

Orlando, Florida, 32807, United States
Gastroenterology Partners of North Houston

Shenandoah, Texas, 77384, United States
Gastroenterology of Greater Orlando

Orange City, Florida, 32763, United States
Gastrointestinal Associates of Rockland

New City, New York, 10956, United States
Gastrointestinal Associates, P.C.

Knoxville, Tennessee, 37909, United States
Gastrointestinal Specs Lng Is

Wantagh, New York, 11793, United States
Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States
Guardian Angel Research Center, LLC

Tampa, Florida, 33614, United States
Hackensack Digestive Disease Associates

Hackensack, New Jersey, 07601, United States
Hassman Research Institute

Berlin, New Jersey, 08009, United States
Health Awareness, Inc

Jupiter, Florida, 33458, United States
Helios Clinical Research lLC

Jackson, Tennessee, 38305, United States
Helping Hands Healthcare Group

Fullerton, California, 92831, United States
Holy Family Memorial, Inc

Manitowoc, Wisconsin, 54221, United States
Hope Clinical Research

Canoga Park, California, 91303, United States
Hope Research Institute

Chandler, Arizona, 85224, United States
Hope Research Institute

Glendale, Arizona, 85308, United States
Houston Digestive Diseases Consultants

Houston, Texas, 77074, United States
InSite Digestive Health Care

Arcadia, California, 91006, United States
InSite Digestive Health Care - Gastroenterology Associates

Pasadena, California, 91105, United States
InSite Digestive Health Care-San Gabriel

Oxnard, California, 93030, United States
Infinite Clinical Trials

Riverdale, Georgia, 30274, United States
Innovative Medical Research of South Florida, Inc.

Aventura, Florida, 33180, United States
Intercity Gastroenterology

Fresh Meadows, New York, 11366, United States
Invocare Medical Research & Healthcare Center

West Columbia, South Carolina, 29169, United States
Jasper Summit Research LLC

Jasper, Alabama, 35501, United States
Javara Research

Charlotte, North Carolina, 28210, United States
Jupiter Medical Center

Jupiter, Florida, 33458, United States
Kansas Gastroenterology, LLC

Wichita, Kansas, 67226, United States
Knowledge Research Center

Orange, California, 92868, United States
LA Gastroenterology Group

Los Angeles, California, 90004, United States
Lakeview Clinical Research

Guntersville, Alabama, 35976, United States
Lillestol Research, LLC

Fargo, North Dakota, 58104, United States
Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States
Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108, United States
META Medical Research Institute

Dayton, Ohio, 45432, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc

Toluca Lake, California, 91602, United States
Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States
Medical Associates Research Group

San Diego, California, 92123, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medication Management LLC

Greensboro, North Carolina, 27408, United States
Memorial Hermann Surgery Center

Houston, Texas, 77084, United States
Meridian Clinical Research

Rockville, Maryland, 20854, United States
Metro Atlanta Gastroenterology, LLC.

Atlanta, Georgia, 30342, United States
Mid-Atlantic GI Research

Greenbelt, Maryland, 20770, United States
Midwest Regional Health Services, LLC/CCT Research

Omaha, Nebraska, 68130, United States
Multi-Specialty Research Associates

Lake City, Florida, 32055, United States
NY Scientific

Brooklyn, New York, 11235, United States
North Jersey Gastroenterology

Wayne, New Jersey, 07470, United States
Northeast GI Research Division

Concord, North Carolina, 28027, United States
Northern California Research

Sacramento, California, 95821, United States
Northlake Gastroenterology Associates

Covington, Louisiana, 70433, United States
Northlake Gastroenterology Associates

Hammond, Louisiana, 70403, United States
Northshore Gastroenterology & Endoscopy Center

Westlake, Ohio, 44145, United States
Northside Gastroenterology Associates

Cypress, Texas, 77429, United States
Novak Clinical Research

Tucson, Arizona, 85741, United States
Ocala GI Research, LLC

Ocala, Florida, 34471, United States
Onyx Clinical Research

Rochester Hills, Michigan, 48307, United States
Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States
PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States
PMG Research of Salisbury, LLC

Salisbury, North Carolina, 28144, United States
PMG Research of Winston

Winston-Salem, North Carolina, 27103, United States
PPCP Division of Gastroenterology LLC

Summerville, South Carolina, 29486, United States
Palm Tree Clinical, Inc

Palm Springs, California, 92262, United States
Palmetto Research, LLC

Hialeah, Florida, 33016, United States
Paragon RX Clinical, Inc.

Garden Grove, California, 92840, United States
Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States
Piedmont HealthCare, PA

Statesville, North Carolina, 28625, United States
Pinehurst Medical Clinic

Pinehurst, North Carolina, 28374, United States
Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States
Plains Clinical Research Center, LLC

Fargo, North Dakota, 58104, United States
Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States
Precision Research Institute

Chula Vista, California, 91910, United States
Precision Research Institute

San Diego, California, 92114, United States
Preferred Research Partners, Inc

Little Rock, Arkansas, 72211, United States
Premier Gastroenterology

Little Rock, Arkansas, 72211, United States
Prime Medical Group, LLC

Gilbert, Arizona, 85296, United States
Progressive Clinical Research

Bountiful, Utah, 84010, United States
Protenium Clinical Research Inc.

Hurst, Texas, 76054, United States
Quinn Healthcare

Ridgeland, Mississippi, 39157, United States
Reciomed Clinical Research Network, Inc.

Boynton Beach, Florida, 33472, United States
Research Centers of America

Hollywood, Florida, 33024, United States
Revive Research Institute, LLC

Southfield, Michigan, 48034, United States
Robley Rex VA Medical Center

Louisville, Kentucky, 40206, United States
Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107, United States
Rolphe Adult and Pediatric Medicine

Union City, Georgia, 30291, United States
SDG Clinical Research, Inc.

San Diego, California, 92103, United States
SKY Clinical Research Network Group

Lawrenceville, Georgia, 30044, United States
Saint Louis University GI & Hepatology Research Unit

St Louis, Missouri, 63104, United States
Sam Moskowitz, MD

Brooklyn, New York, 11234, United States
San Diego Gastroenterology Medical Associates

San Diego, California, 92103, United States
Sarkis Clinical Trials

Ocala, Florida, 34474, United States
Skyline Medical Center, PC/CCT Research

Elkhorn, Nebraska, 68022, United States
Smart Medical Research

Richmond Hill, New York, 11419, United States
South Carolina Clinical Research LLC

Orangeburg, South Carolina, 29118, United States
South Island Gastro

Lawrence, New York, 11559, United States
South Suburban Gastroenterology

South Weymouth, Massachusetts, 02190, United States
Southeast Medical Research/Elms Research

North Charleston, South Carolina, 29406, United States
Southeast Valley Gastroenterology

Chandler, Arizona, 85224, United States
Southern Therapy and Advanced Research

Jackson, Mississippi, 39216, United States
Suburban Gastroenterology Ltd

Naperville, Illinois, 60540, United States
Sundance Clinical Research

St Louis, Missouri, 63141, United States
Susquehanna Research Group

Harrisburg, Pennsylvania, 17110, United States
Susquehanna Research Group, LLC

Camp Hill, Pennsylvania, 17011, United States
Syracuse Gastro Associates

Syracuse, New York, 13210, United States
Teaneck Gastroenterology Associates

Teaneck, New Jersey, 07666, United States
Texas Gastro Consultants

Tomball, Texas, 77375, United States
Texas Gastroenterology Associates/A1 Clinical Network

Spring, Texas, 77386, United States
The Center for Gastrointestinal Disorders

Hollywood, Florida, 33021, United States
The Gastroenterology Group

Reston, Virginia, 20191, United States
The Jackson Clinic

Jackson, Tennessee, 38305, United States
The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States
The Oregon Clinic - Gastroenterology East

Portland, Oregon, 97220, United States
Tidewater Physicians Multispecialty Group Clinical Research

Williamsburg, Virginia, 23188, United States
Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663, United States
Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, 41017, United States
Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States
UNC Division of Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599, United States
US Digestive Health at Blair

Altoona, Pennsylvania, 16602, United States
Uma Mohan MD PA

Cypress, Texas, 77429, United States
United Medical Doctors

Irvine, California, 92618, United States
University Clinical Research-DeLand, LLC dba Accel Research Sites

Lake Mary, Florida, 32746, United States
University Clinical Research-DeLand, LLC dba Accel Research Sites

Melbourne, Florida, 32901, United States
University of Chicago Medicine

Chicago, Illinois, 60654, United States
University of Cincinnati

Cincinnati, Ohio, 45267, United States
University of Florida College of Medicine

Gainesville, Florida, 32610, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Louisville Research Foundation

Louisville, Kentucky, 40202, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Southern California

Los Angeles, California, 90033, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Toledo Internal Medicine Clinic

Toledo, Ohio, 43606, United States
Valley Gastroenterology Associates

Beaver Falls, Pennsylvania, 15010, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States
Velocity Clinical Research

Spokane, Washington, 99202, United States
Ventura County Gastroenterology Medical Group

Camarillo, California, 93012, United States
Verity Research

Fairfax, Virginia, 22031, United States
WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States
WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States
Washington Gastroenterology

Bellevue, Washington, 98004, United States
Washington University School of Medicine Gastroenterology

St Louis, Missouri, 63110, United States
West Glen Gastrointestinal Consultants, P.A.

Shawnee, Kansas, 66217, United States
Western Washington Medical Group, Inc

Everett, Washington, 98208, United States
Wilmington Health

Wilmington, North Carolina, 28401, United States
Wr-Crcn, Llc

Las Vegas, Nevada, 89148, United States
Yale University

New Haven, Connecticut, 06519, United States

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