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

Colorectal Cancer Clinical Trial

— ECLIPSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04136002
• Other study ID #: 02-GI-002
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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