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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04136002
Other study ID # 02-GI-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 8, 2019
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Guardant Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 screen-relevant, average risk population.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44467
Est. completion date December 31, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 84 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Lovelace Scientific Resources, Inc. Albuquerque New Mexico
United States Eastern Pennsylvania GI & Liver Specialists Allentown Pennsylvania
United States US Digestive Health at Blair Altoona Pennsylvania
United States Associated Gastroenterology Medical Group Anaheim California
United States University of Michigan Ann Arbor Michigan
United States Pinnacle Research Group, LLC Anniston Alabama
United States InSite Digestive Health Care Arcadia California
United States Digestive Health Partners Asheville North Carolina
United States Digestive Health Care of Georgia Atlanta Georgia
United States Emory University School of Medicine Atlanta Georgia
United States Metro Atlanta Gastroenterology, LLC. Atlanta Georgia
United States Elligo Clinical Research Center Austin Tennessee
United States Innovative Medical Research of South Florida, Inc. Aventura Florida
United States Gastroenterology Associates of Cleveland Beachwood Ohio
United States Valley Gastroenterology Associates Beaver Falls Pennsylvania
United States Dayton Gastroenterology Beavercreek Ohio
United States Dayton Gastroenterology, Inc. Beavercreek Ohio
United States Washington Gastroenterology Bellevue Washington
United States Hassman Research Institute Berlin New Jersey
United States Progressive Clinical Research Bountiful Utah
United States Reciomed Clinical Research Network, Inc. Boynton Beach Florida
United States Allied Health Clinical Research Organization, LLC Brick New Jersey
United States Gastroenterology Associates of Fairfield County Bridgeport Connecticut
United States NY Scientific Brooklyn New York
United States Sam Moskowitz, MD Brooklyn New York
United States Gastroenterology Burlingame California
United States Ventura County Gastroenterology Medical Group Camarillo California
United States Associated Gastroenterologists of Central New York, Camillus Camillus New York
United States Susquehanna Research Group, LLC Camp Hill Pennsylvania
United States Alliance Research Institute Canoga Park California
United States Hope Clinical Research Canoga Park California
United States Cary Gastro Associates Cary North Carolina
United States Christie Clinic Champaign Illinois
United States Hope Research Institute Chandler Arizona
United States Southeast Valley Gastroenterology Chandler Arizona
United States UNC Division of Gastroenterology and Hepatology Chapel Hill North Carolina
United States Carolina Digestive Health Associates, PA Charlotte North Carolina
United States Carolinas Research Center Charlotte North Carolina
United States Charlotte Gastroenterology & Hepatology, PLLC Charlotte North Carolina
United States Javara Research Charlotte North Carolina
United States Charlottesville Medical Research Charlottesville Virginia
United States Erlanger Health Clinical Resarch Chattanooga Tennessee
United States WR-ClinSearch, LLC Chattanooga Tennessee
United States Digestive Health Specialists Chelmsford Massachusetts
United States Gastroenterology Associates of Tidewater Chesapeake Virginia
United States Clinical Research Professionals, LLC Chesterfield Missouri
United States Curebase Chicago Illinois
United States University of Chicago Medicine Chicago Illinois
United States Gastro SB Clinic Chula Vista California
United States Precision Research Institute Chula Vista California
United States Gastro Health Research Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio
United States Gastroenterology Associates Of New Jersey Clifton New Jersey
United States Gastro Center of Maryland Columbia Maryland
United States ClinOhio Research Services Columbus Ohio
United States Columbus Regional Research Institute Columbus Georgia
United States Gastroenterology Associates of Mississippi Columbus Mississippi
United States Carolina Digestive Health Associates, PA Concord North Carolina
United States Northeast GI Research Division Concord North Carolina
United States Clinical Research of South Florida, an AMR Company Coral Gables Florida
United States Northlake Gastroenterology Associates Covington Louisiana
United States GIMED Associates, Inc. Cranston Rhode Island
United States Tri-State Gastroenterology Associates Crestview Hills Kentucky
United States Allied Digestive Disease Center Cypress Texas
United States Northside Gastroenterology Associates Cypress Texas
United States Uma Mohan MD PA Cypress Texas
United States Advance Clinical Research Dayton Ohio
United States META Medical Research Institute Dayton Ohio
United States Dolphin Medical Research Doral Florida
United States Digestive Health Services Downers Grove Illinois
United States Curebase Eagan Minnesota
United States Associated Gastroenterology of Central New York East Syracuse New York
United States Alliance for Multispecialty Research, LLC El Dorado Kansas
United States El Paso Integrated Physicians Group, P.A. El Paso Texas
United States Skyline Medical Center, PC/CCT Research Elkhorn Nebraska
United States Centennial Medical Group Elkridge Maryland
United States BG Clinical Research and affiliate of The Clinical Trials Network, LLC Encinitas California
United States Diagnamics, Inc Encinitas California
United States Gastroenterology Consultants of Augusta Evans Georgia
United States Western Washington Medical Group, Inc Everett Washington
United States Verity Research Fairfax Virginia
United States Lillestol Research, LLC Fargo North Dakota
United States Plains Clinical Research Center, LLC Fargo North Dakota
United States Associated Gastroenterologists of Central New York Fayetteville New York
United States Coastal Research Institute, LLC Fayetteville North Carolina
United States AIG Digestive Disease Research Florham Park New Jersey
United States Frederick Gastroenterology Associates Frederick Maryland
United States Allied Health Clinical Research Organization, LLC Freehold New Jersey
United States Intercity Gastroenterology Fresh Meadows New York
United States Helping Hands Healthcare Group Fullerton California
United States University of Florida College of Medicine Gainesville Florida
United States Paragon RX Clinical, Inc. Garden Grove California
United States Gastro One Germantown Tennessee
United States Prime Medical Group, LLC Gilbert Arizona
United States Hope Research Institute Glendale Arizona
United States Mid-Atlantic GI Research Greenbelt Maryland
United States Medication Management LLC Greensboro North Carolina
United States Digestive Disease Research Center Greenwood South Carolina
United States Lakeview Clinical Research Guntersville Alabama
United States Hackensack Digestive Disease Associates Hackensack New Jersey
United States CMR of Greater New Haven, LLC Hamden Connecticut
United States Northlake Gastroenterology Associates Hammond Louisiana
United States Susquehanna Research Group Harrisburg Pennsylvania
United States Palmetto Research, LLC Hialeah Florida
United States Digestive Healthcare Center Hillsborough New Jersey
United States Edward Hines Jr. VA Hospital Hines Illinois
United States Research Centers of America Hollywood Florida
United States The Center for Gastrointestinal Disorders Hollywood Florida
United States CroNola LLC Houma Louisiana
United States Biopharma Informatic Houston Texas
United States Digestive Health Associates Houston Texas
United States Diversified Medical Practices Houston Texas
United States Houston Digestive Diseases Consultants Houston Texas
United States Memorial Hermann Surgery Center Houston Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Digestive Health Research of Southern California Huntington Beach California
United States Medical Affiliated Research Center Huntsville Alabama
United States Protenium Clinical Research Inc. Hurst Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States United Medical Doctors Irvine California
United States Allied Health Clinical Research Organization Jackson New Jersey
United States Helios Clinical Research lLC Jackson Tennessee
United States Southern Therapy and Advanced Research Jackson Mississippi
United States The Jackson Clinic Jackson Tennessee
United States The Jackson Clinic, PA Jackson Tennessee
United States Jasper Summit Research LLC Jasper Alabama
United States East Tennessee Research Institute Johnson City Tennessee
United States Health Awareness, Inc Jupiter Florida
United States Jupiter Medical Center Jupiter Florida
United States Tri-Cities Gastroenterology Kingsport Tennessee
United States Gastrointestinal Associates, P.C. Knoxville Tennessee
United States Gastroclinic Lafayette Louisiana
United States Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research Lake Barrington Illinois
United States Clinical Trials of SWLA, LLC Lake Charles Louisiana
United States Multi-Specialty Research Associates Lake City Florida
United States University Clinical Research-DeLand, LLC dba Accel Research Sites Lake Mary Florida
United States Florida Research Institute Lakewood Ranch Florida
United States Gastro Care Institute Lancaster California
United States Excel Clinical Research Las Vegas Nevada
United States Wr-Crcn, Llc Las Vegas Nevada
United States South Island Gastro Lawrence New York
United States SKY Clinical Research Network Group Lawrenceville Georgia
United States Preferred Research Partners, Inc Little Rock Arkansas
United States Premier Gastroenterology Little Rock Arkansas
United States Gastroenterology Associates of Beverly Hills Los Angeles California
United States LA Gastroenterology Group Los Angeles California
United States University of Southern California Los Angeles California
United States Robley Rex VA Medical Center Louisville Kentucky
United States University of Louisville Research Foundation Louisville Kentucky
United States Blue Ridge Medical Research Lynchburg Virginia
United States Holy Family Memorial, Inc Manitowoc Wisconsin
United States East End Gastroenterology & Hepatology Manorville New York
United States Biopharma Informatic McAllen Texas
United States University Clinical Research-DeLand, LLC dba Accel Research Sites Melbourne Florida
United States Great Lakes Gastroenterology Mentor Ohio
United States Crystal Biomedical Research Miami Lakes Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Delta Research Partners Monroe Louisiana
United States Gastroenterology Associates Of New Jersey Montclair New Jersey
United States Coastal Carolina Research Center Mount Pleasant South Carolina
United States Suburban Gastroenterology Ltd Naperville Illinois
United States GIMED Associates, Inc. Narragansett Rhode Island
United States Vanderbilt University Medical Center Nashville Tennessee
United States Gastrointestinal Associates of Rockland New City New York
United States Yale University New Haven Connecticut
United States Southeast Medical Research/Elms Research North Charleston South Carolina
United States Arkansas Gastroenterology North Little Rock Arkansas
United States Comprehensive Gastrointestinal Health Northbrook Illinois
United States DM Clinical Research Oak Lawn Illinois
United States Ocala GI Research, LLC Ocala Florida
United States Sarkis Clinical Trials Ocala Florida
United States Dr. Howard N. Guss and Dr. Gagan Beri Ocean City New Jersey
United States Advanced Research Institute Ogden Utah
United States Digestive Disease Specialists, Inc Oklahoma City Oklahoma
United States Midwest Regional Health Services, LLC/CCT Research Omaha Nebraska
United States Knowledge Research Center Orange California
United States Gastroenterology of Greater Orlando Orange City Florida
United States South Carolina Clinical Research LLC Orangeburg South Carolina
United States Gastroenterology Institute of Orlando Orlando Florida
United States InSite Digestive Health Care-San Gabriel Oxnard California
United States Advanced Gastroenterology Associates, LLC Palm Harbor Florida
United States Desert Oasis Healthcare Medical Group Palm Springs California
United States Palm Tree Clinical, Inc Palm Springs California
United States Gastroenterology Consultants, P.A. Pasadena Texas
United States InSite Digestive Health Care - Gastroenterology Associates Pasadena California
United States Einstein Medical Center Department of Digestive Disease and Transplantation Philadelphia Pennsylvania
United States Perelman Center for Advanced Medicine Philadelphia Pennsylvania
United States "Forty-Third Medical Associates Absolute Clinical Research" Phoenix Arizona
United States GI Research Associates, LLC Phoenix Arizona
United States Pinehurst Medical Clinic Pinehurst North Carolina
United States Fanno Creek Group Portland Oregon
United States The Oregon Clinic - Gastroenterology East Portland Oregon
United States Carolina's GI Research, LLC Raleigh North Carolina
United States PMG Research of Raleigh Raleigh North Carolina
United States Advanced Research Institute Reno Nevada
United States Gastroenterology Consultants Reno Nevada
United States Gastroenterology Consultants Reno Nevada
United States The Gastroenterology Group Reston Virginia
United States GI Select Health Research, LLC Richmond Virginia
United States Smart Medical Research Richmond Hill New York
United States Quinn Healthcare Ridgeland Mississippi
United States Gastroenterology Associates Of New Jersey Ridgewood New Jersey
United States Infinite Clinical Trials Riverdale Georgia
United States Onyx Clinical Research Rochester Hills Michigan
United States Rockford Gastroenterology Associates, Ltd. Rockford Illinois
United States Meridian Clinical Research Rockville Maryland
United States Boice Willis Clinic, PA Rocky Mount North Carolina
United States Northern California Research Sacramento California
United States Covenant HealthCare Saginaw Michigan
United States Digestive Health Specialists, LLC Saint Joseph Missouri
United States Saint Louis University GI & Hepatology Research Unit Saint Louis Missouri
United States Sundance Clinical Research Saint Louis Missouri
United States Washington University School of Medicine Gastroenterology Saint Louis Missouri
United States PMG Research of Salisbury, LLC Salisbury North Carolina
United States Clinical Associates in Research Therapeutics of America San Antonio Texas
United States Medical Associates Research Group San Diego California
United States Precision Research Institute San Diego California
United States San Diego Gastroenterology Medical Associates San Diego California
United States SDG Clinical Research, Inc. San Diego California
United States Advanced Research Institute Granite Peaks Gastroenterology Sandy Utah
United States WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia
United States West Glen Gastrointestinal Consultants, P.A. Shawnee Mission Kansas
United States Gastroenterology Partners of North Houston Shenandoah Texas
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Digestive Research Alliance of Michiana South Bend Indiana
United States South Suburban Gastroenterology South Weymouth Massachusetts
United States Revive Research Institute, LLC Southfield Michigan
United States Velocity Clinical Research Spokane Washington
United States Texas Gastroenterology Associates/A1 Clinical Network Spring Texas
United States DSI Research, LLC Springboro Ohio
United States Piedmont HealthCare, PA Statesville North Carolina
United States GI Associates Stevens Point Wisconsin
United States Gastroenterology Associates of Texas, PA Sugar Land Texas
United States PPCP Division of Gastroenterology LLC Summerville South Carolina
United States Precision Clinical Research, LLC Sunrise Florida
United States Syracuse Gastro Associates Syracuse New York
United States Guardian Angel Research Center, LLC Tampa Florida
United States Teaneck Gastroenterology Associates Teaneck New Jersey
United States FOMAT Simoni AGI Medical Thousand Oaks California
United States University of Toledo Internal Medicine Clinic Toledo Ohio
United States Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc Toluca Lake California
United States Texas Gastro Consultants Tomball Texas
United States Clinical Research Institute of Michigan, LLC Troy Michigan
United States Del Sol Research Management, LLC Tucson Arizona
United States Novak Clinical Research Tucson Arizona
United States Options Health Research, LLC Tulsa Oklahoma
United States Advanced Gastroenterology Group Union New Jersey
United States Advanced Gastroenterology Union City Tennessee
United States Rolphe Adult and Pediatric Medicine Union City Georgia
United States Frontier Clinical Research, LLC Uniontown Pennsylvania
United States Digestive Disease Medicine Of Central New York Utica New York
United States GastroCare LI Valley Stream New York
United States Clinical Research of California Walnut Creek California
United States Curebase Walnut Creek California
United States Gastrointestinal Specs Lng Is Wantagh New York
United States Avamar Gastroenterology and Center Warren Ohio
United States GI Associates Wausau Wisconsin
United States Gastroenterology Associates Of New Jersey Wayne New Jersey
United States North Jersey Gastroenterology Wayne New Jersey
United States Invocare Medical Research & Healthcare Center West Columbia South Carolina
United States Eric L. Tatar, MD West Nyack New York
United States Northshore Gastroenterology & Endoscopy Center Westlake Ohio
United States Alliance for Multispecialty Research-Wichita West Wichita Kansas
United States Kansas Gastroenterology, LLC Wichita Kansas
United States Digestive Health Research of North Texas Wichita Falls Texas
United States Tidewater Physicians Multispecialty Group Clinical Research Williamsburg Virginia
United States Trial Management Associates, LLC Wilmington North Carolina
United States Wilmington Health Wilmington North Carolina
United States PMG Research of Winston Winston-Salem North Carolina
United States Gastroenterology Associates Of New Jersey Woodland Park New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Guardant Health, Inc. Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of colorectal cancer detection Sensitivity of colorectal cancer detection 60 days
Primary Specificity of advanced neoplasia detection Specificity of advanced neoplasia detection 60 days
Secondary Positive predictive value of colorectal cancer detection Positive predictive value of colorectal cancer detection 60 days
Secondary Negative predictive value of colorectal cancer detection Negative predictive value of colorectal cancer detection 60 days
Secondary Sensitivity and specificity of advanced adenoma detection Sensitivity and specificity of advanced adenoma detection 60 days
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