AzTrials
AzTrials

Colorectal CancerECLIPSENCT04136002

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

An observational study of Colorectal Cancer, run by Guardant Health, Inc. at 271 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 84 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
How many people
44,467 participants
Where
271 sitesUnited States
Study dates
8 Oct 2019to 5 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

271 sites in 1 country.

271 sites in 1 country

United States271 sites

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87108

  • Eastern Pennsylvania GI & Liver Specialists

    Allentown, Pennsylvania, 18104

  • US Digestive Health at Blair

    Altoona, Pennsylvania, 16602

  • Associated Gastroenterology Medical Group

    Anaheim, California, 92801

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • InSite Digestive Health Care

    Arcadia, California, 91006

  • Digestive Health Partners

    Asheville, North Carolina, 28801

  • Digestive Health Care of Georgia

    Atlanta, Georgia, 30309

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Metro Atlanta Gastroenterology, LLC.

    Atlanta, Georgia, 30342

  • Elligo Clinical Research Center

    Austin, Tennessee, 78738

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida, 33180

  • Gastroenterology Associates of Cleveland

    Beachwood, Ohio, 44122

  • Valley Gastroenterology Associates

    Beaver Falls, Pennsylvania, 15010

  • Dayton Gastroenterology, Inc.

    Beavercreek, Ohio, 45440

  • Dayton Gastroenterology

    Beavercreek, Ohio, 45440

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Progressive Clinical Research

    Bountiful, Utah, 84010

  • Reciomed Clinical Research Network, Inc.

    Boynton Beach, Florida, 33472

  • Allied Health Clinical Research Organization, LLC

    Brick, New Jersey, 08724

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Sam Moskowitz, MD

    Brooklyn, New York, 11234

  • NY Scientific

    Brooklyn, New York, 11235

  • Gastroenterology

    Burlingame, California, 94010

  • Ventura County Gastroenterology Medical Group

    Camarillo, California, 93012

  • Associated Gastroenterologists of Central New York, Camillus

    Camillus, New York, 13031

  • Susquehanna Research Group, LLC

    Camp Hill, Pennsylvania, 17011

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Alliance Research Institute

    Canoga Park, California, 91304

  • Cary Gastro Associates

    Cary, North Carolina, 27518

  • Christie Clinic

    Champaign, Illinois, 61822

  • Hope Research Institute

    Chandler, Arizona, 85224

  • Southeast Valley Gastroenterology

    Chandler, Arizona, 85224

  • UNC Division of Gastroenterology and Hepatology

    Chapel Hill, North Carolina, 27599

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • Carolina Digestive Health Associates, PA

    Charlotte, North Carolina, 28210

  • Javara Research

    Charlotte, North Carolina, 28210

  • Carolinas Research Center

    Charlotte, North Carolina, 28215

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Erlanger Health Clinical Resarch

    Chattanooga, Tennessee, 37403

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Digestive Health Specialists

    Chelmsford, Massachusetts, 01824

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Professionals, LLC

    Chesterfield, Missouri, 63005

  • University of Chicago Medicine

    Chicago, Illinois, 60654

  • Curebase

    Chicago, Illinois, 60656

  • Gastro SB Clinic

    Chula Vista, California, 91910

  • Precision Research Institute

    Chula Vista, California, 91910

  • Gastro Health Research

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Gastroenterology Associates Of New Jersey

    Clifton, New Jersey, 07013

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Gastroenterology Associates of Mississippi

    Columbus, Mississippi, 39705

  • ClinOhio Research Services

    Columbus, Ohio, 43213

  • Carolina Digestive Health Associates, PA

    Concord, North Carolina, 28025

  • Northeast GI Research Division

    Concord, North Carolina, 28027

  • Clinical Research of South Florida, an AMR Company

    Coral Gables, Florida, 33134

  • Northlake Gastroenterology Associates

    Covington, Louisiana, 70433

  • GIMED Associates, Inc.

    Cranston, Rhode Island, 02920

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky, 41017

  • Allied Digestive Disease Center

    Cypress, Texas, 77429

  • Northside Gastroenterology Associates

    Cypress, Texas, 77429

  • Uma Mohan MD PA

    Cypress, Texas, 77429

  • Advance Clinical Research

    Dayton, Ohio, 45417

  • META Medical Research Institute

    Dayton, Ohio, 45432

  • Dolphin Medical Research

    Doral, Florida, 33172

  • Digestive Health Services

    Downers Grove, Illinois, 60515

  • Curebase

    Eagan, Minnesota, 55122

  • Associated Gastroenterology of Central New York

    East Syracuse, New York, 13057

  • Alliance for Multispecialty Research, LLC

    El Dorado, Kansas, 67042

  • El Paso Integrated Physicians Group, P.A.

    El Paso, Texas, 79912

  • Skyline Medical Center, PC/CCT Research

    Elkhorn, Nebraska, 68022

  • Centennial Medical Group

    Elkridge, Maryland, 21075

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

    Encinitas, California, 92024

  • Diagnamics, Inc

    Encinitas, California, 92024

  • Gastroenterology Consultants of Augusta

    Evans, Georgia, 30809

  • Western Washington Medical Group, Inc

    Everett, Washington, 98208

  • Verity Research

    Fairfax, Virginia, 22031

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Plains Clinical Research Center, LLC

    Fargo, North Dakota, 58104

  • Associated Gastroenterologists of Central New York

    Fayetteville, New York, 13066

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina, 28304

  • AIG Digestive Disease Research

    Florham Park, New Jersey, 07932

  • Frederick Gastroenterology Associates

    Frederick, Maryland, 21701

  • Allied Health Clinical Research Organization, LLC

    Freehold, New Jersey, 07728

  • Intercity Gastroenterology

    Fresh Meadows, New York, 11366

  • Helping Hands Healthcare Group

    Fullerton, California, 92831

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Paragon RX Clinical, Inc.

    Garden Grove, California, 92840

  • Gastro One

    Germantown, Tennessee, 38138

  • Prime Medical Group, LLC

    Gilbert, Arizona, 85296

  • Hope Research Institute

    Glendale, Arizona, 85308

  • Mid-Atlantic GI Research

    Greenbelt, Maryland, 20770

  • Medication Management LLC

    Greensboro, North Carolina, 27408

  • Digestive Disease Research Center

    Greenwood, South Carolina, 29646

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • Hackensack Digestive Disease Associates

    Hackensack, New Jersey, 07601

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Northlake Gastroenterology Associates

    Hammond, Louisiana, 70403

  • Susquehanna Research Group

    Harrisburg, Pennsylvania, 17110

  • Palmetto Research, LLC

    Hialeah, Florida, 33016

  • Digestive Healthcare Center

    Hillsborough, New Jersey, 08844

  • Edward Hines Jr. VA Hospital

    Hines, Illinois, 60141

  • The Center for Gastrointestinal Disorders

    Hollywood, Florida, 33021

  • Research Centers of America

    Hollywood, Florida, 33024

  • CroNola LLC

    Houma, Louisiana, 70360

  • Digestive Health Associates

    Houston, Texas, 77024

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Biopharma Informatic

    Houston, Texas, 77055

  • Diversified Medical Practices

    Houston, Texas, 77057

  • Houston Digestive Diseases Consultants

    Houston, Texas, 77074

  • Memorial Hermann Surgery Center

    Houston, Texas, 77084

  • Digestive Health Research of Southern California

    Huntington Beach, California, 92647

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Protenium Clinical Research Inc.

    Hurst, Texas, 76054

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • United Medical Doctors

    Irvine, California, 92618

  • Southern Therapy and Advanced Research

    Jackson, Mississippi, 39216

  • Allied Health Clinical Research Organization

    Jackson, New Jersey, 08527

  • Helios Clinical Research lLC

    Jackson, Tennessee, 38305

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38305

  • The Jackson Clinic

    Jackson, Tennessee, 38305

  • Jasper Summit Research LLC

    Jasper, Alabama, 35501

  • East Tennessee Research Institute

    Johnson City, Tennessee, 37604

  • Health Awareness, Inc

    Jupiter, Florida, 33458

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee, 37663

  • Gastrointestinal Associates, P.C.

    Knoxville, Tennessee, 37909

  • Gastroclinic

    Lafayette, Louisiana, 70503

  • Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research

    Lake Barrington, Illinois, 60010

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • Multi-Specialty Research Associates

    Lake City, Florida, 32055

  • University Clinical Research-DeLand, LLC dba Accel Research Sites

    Lake Mary, Florida, 32746

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Gastro Care Institute

    Lancaster, California, 93534

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Wr-Crcn, Llc

    Las Vegas, Nevada, 89148

  • South Island Gastro

    Lawrence, New York, 11559

  • SKY Clinical Research Network Group

    Lawrenceville, Georgia, 30044

  • Preferred Research Partners, Inc

    Little Rock, Arkansas, 72211

  • Premier Gastroenterology

    Little Rock, Arkansas, 72211

  • LA Gastroenterology Group

    Los Angeles, California, 90004

  • University of Southern California

    Los Angeles, California, 90033

  • Gastroenterology Associates of Beverly Hills

    Los Angeles, California, 90048

  • University of Louisville Research Foundation

    Louisville, Kentucky, 40202

  • Robley Rex VA Medical Center

    Louisville, Kentucky, 40206

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Holy Family Memorial, Inc

    Manitowoc, Wisconsin, 54221

  • East End Gastroenterology & Hepatology

    Manorville, New York, 11949

  • Biopharma Informatic

    McAllen, Texas, 78503

  • University Clinical Research-DeLand, LLC dba Accel Research Sites

    Melbourne, Florida, 32901

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Crystal Biomedical Research

    Miami Lakes, Florida, 33014

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • Gastroenterology Associates Of New Jersey

    Montclair, New Jersey, 07042

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Suburban Gastroenterology Ltd

    Naperville, Illinois, 60540

  • GIMED Associates, Inc.

    Narragansett, Rhode Island, 02882

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Gastrointestinal Associates of Rockland

    New City, New York, 10956

  • Yale University

    New Haven, Connecticut, 06519

  • Southeast Medical Research/Elms Research

    North Charleston, South Carolina, 29406

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Comprehensive Gastrointestinal Health

    Northbrook, Illinois, 60062

  • DM Clinical Research

    Oak Lawn, Illinois, 60453

  • Ocala GI Research, LLC

    Ocala, Florida, 34471

  • Sarkis Clinical Trials

    Ocala, Florida, 34474

  • Dr. Howard N. Guss and Dr. Gagan Beri

    Ocean City, New Jersey, 07712

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Digestive Disease Specialists, Inc

    Oklahoma City, Oklahoma, 73112

  • Midwest Regional Health Services, LLC/CCT Research

    Omaha, Nebraska, 68130

  • Knowledge Research Center

    Orange, California, 92868

  • Gastroenterology of Greater Orlando

    Orange City, Florida, 32763

  • South Carolina Clinical Research LLC

    Orangeburg, South Carolina, 29118

  • Gastroenterology Institute of Orlando

    Orlando, Florida, 32807

  • InSite Digestive Health Care-San Gabriel

    Oxnard, California, 93030

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

  • Palm Tree Clinical, Inc

    Palm Springs, California, 92262

  • InSite Digestive Health Care - Gastroenterology Associates

    Pasadena, California, 91105

  • Gastroenterology Consultants, P.A.

    Pasadena, Texas, 77504

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Einstein Medical Center Department of Digestive Disease and Transplantation

    Philadelphia, Pennsylvania, 19141

  • GI Research Associates, LLC

    Phoenix, Arizona, 85037

  • "Forty-Third Medical Associates Absolute Clinical Research"

    Phoenix, Arizona, 85051

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28374

  • Fanno Creek Group

    Portland, Oregon, 97219

  • The Oregon Clinic - Gastroenterology East

    Portland, Oregon, 97220

  • Carolina's GI Research, LLC

    Raleigh, North Carolina, 27607

  • PMG Research of Raleigh

    Raleigh, North Carolina, 27609

  • Gastroenterology Consultants

    Reno, Nevada, 89502

  • Advanced Research Institute

    Reno, Nevada, 89511

  • Gastroenterology Consultants

    Reno, Nevada, 89521

  • The Gastroenterology Group

    Reston, Virginia, 20191

  • GI Select Health Research, LLC

    Richmond, Virginia, 23236

  • Smart Medical Research

    Richmond Hill, New York, 11419

  • Quinn Healthcare

    Ridgeland, Mississippi, 39157

  • Gastroenterology Associates Of New Jersey

    Ridgewood, New Jersey, 07450

  • Infinite Clinical Trials

    Riverdale, Georgia, 30274

  • Onyx Clinical Research

    Rochester Hills, Michigan, 48307

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107

  • Meridian Clinical Research

    Rockville, Maryland, 20854

  • Boice Willis Clinic, PA

    Rocky Mount, North Carolina, 27804

  • Northern California Research

    Sacramento, California, 95821

  • Covenant HealthCare

    Saginaw, Michigan, 48602

  • Digestive Health Specialists, LLC

    Saint Joseph, Missouri, 64057

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • Clinical Associates in Research Therapeutics of America

    San Antonio, Texas, 78212

  • San Diego Gastroenterology Medical Associates

    San Diego, California, 92103

  • SDG Clinical Research, Inc.

    San Diego, California, 92103

  • Precision Research Institute

    San Diego, California, 92114

  • Medical Associates Research Group

    San Diego, California, 92123

  • Advanced Research Institute Granite Peaks Gastroenterology

    Sandy City, Utah, 84092

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • West Glen Gastrointestinal Consultants, P.A.

    Shawnee, Kansas, 66217

  • Gastroenterology Partners of North Houston

    Shenandoah, Texas, 77384

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Digestive Research Alliance of Michiana

    South Bend, Indiana, 46635

  • South Suburban Gastroenterology

    South Weymouth, Massachusetts, 02190

  • Revive Research Institute, LLC

    Southfield, Michigan, 48034

  • Velocity Clinical Research

    Spokane, Washington, 99202

  • Texas Gastroenterology Associates/A1 Clinical Network

    Spring, Texas, 77386

  • DSI Research, LLC

    Springboro, Ohio, 45066

  • Saint Louis University GI & Hepatology Research Unit

    St Louis, Missouri, 63104

  • Washington University School of Medicine Gastroenterology

    St Louis, Missouri, 63110

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Piedmont HealthCare, PA

    Statesville, North Carolina, 28625

  • GI Associates

    Stevens Point, Wisconsin, 54482

  • Gastroenterology Associates of Texas, PA

    Sugar Land, Texas, 77479

  • PPCP Division of Gastroenterology LLC

    Summerville, South Carolina, 29486

  • Precision Clinical Research, LLC

    Sunrise, Florida, 33351

  • Syracuse Gastro Associates

    Syracuse, New York, 13210

  • Guardian Angel Research Center, LLC

    Tampa, Florida, 33614

  • Teaneck Gastroenterology Associates

    Teaneck, New Jersey, 07666

  • FOMAT Simoni AGI Medical

    Thousand Oaks, California, 91360

  • University of Toledo Internal Medicine Clinic

    Toledo, Ohio, 43606

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

    Toluca Lake, California, 91602

  • Texas Gastro Consultants

    Tomball, Texas, 77375

  • Clinical Research Institute of Michigan, LLC

    Troy, Michigan, 48098

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Novak Clinical Research

    Tucson, Arizona, 85741

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Del Sol Research Management, LLC

    Tuscon, Arizona, 85715

  • Advanced Gastroenterology Group

    Union, New Jersey, 07083

  • Rolphe Adult and Pediatric Medicine

    Union City, Georgia, 30291

  • Advanced Gastroenterology

    Union City, Tennessee, 38261

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401

  • Digestive Disease Medicine Of Central New York

    Utica, New York, 13502

  • GastroCare LI

    Valley Stream, New York, 11581

  • Curebase

    Walnut Creek, California, 91789

  • Clinical Research of California

    Walnut Creek, California, 94598

  • Gastrointestinal Specs Lng Is

    Wantagh, New York, 11793

  • Avamar Gastroenterology and Center

    Warren, Ohio, 44484

  • GI Associates

    Wausau, Wisconsin, 54401

  • Gastroenterology Associates Of New Jersey

    Wayne, New Jersey, 07470

  • North Jersey Gastroenterology

    Wayne, New Jersey, 07470

  • Invocare Medical Research & Healthcare Center

    West Columbia, South Carolina, 29169

  • Eric L. Tatar, MD

    West Nyack, New York, 10994

  • Northshore Gastroenterology & Endoscopy Center

    Westlake, Ohio, 44145

  • Alliance for Multispecialty Research-Wichita West

    Wichita, Kansas, 67205

  • Kansas Gastroenterology, LLC

    Wichita, Kansas, 67226

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 76301

  • Tidewater Physicians Multispecialty Group Clinical Research

    Williamsburg, Virginia, 23188

  • Wilmington Health

    Wilmington, North Carolina, 28401

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • PMG Research of Winston

    Winston-Salem, North Carolina, 27103

  • Gastroenterology Associates Of New Jersey

    Woodland Park, New Jersey, 07424

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Colorectal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of colorectal cancer detection

    Sensitivity of colorectal cancer detection

    Measured: 60 days

  2. Specificity of advanced neoplasia detection

    Specificity of advanced neoplasia detection

    Measured: 60 days

Secondary outcomes (3)

  1. Positive predictive value of colorectal cancer detection

    Positive predictive value of colorectal cancer detection

    Measured: 60 days

  2. Negative predictive value of colorectal cancer detection

    Negative predictive value of colorectal cancer detection

    Measured: 60 days

  3. Sensitivity and specificity of advanced adenoma detection

    Sensitivity and specificity of advanced adenoma detection

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start8 Oct 2019
  3. Primary completion20 Mar 2024
  4. Study completion5 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44,467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136002
Sponsor's protocol ID
02-GI-002
Acronym
ECLIPSE
Status last verified
May 2026
First submitted
21 Oct 2019
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38477993

  • 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.

    PubMed 38477985

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Guardant Health, Inc. at 271 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 271 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of colorectal cancer detection (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04136002, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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