Ireland
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Active, not recruiting Observational

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

NCT04136002 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2019-10-08
Last updated
2026-05-14

Condition(s) studied

Colorectal Cancer

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
84 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Sensitivity of colorectal cancer detection — 60 days
    Sensitivity of colorectal cancer detection
  • Specificity of advanced neoplasia detection — 60 days
    Specificity of advanced neoplasia detection

Trial sites (271)

FacilityCityRegionStatus
Pinnacle Research Group, LLC Anniston Alabama
Lakeview Clinical Research Guntersville Alabama
Medical Affiliated Research Center Huntsville Alabama
Jasper Summit Research LLC Jasper Alabama
Hope Research Institute Chandler Arizona
Southeast Valley Gastroenterology Chandler Arizona
Prime Medical Group, LLC Gilbert Arizona
Hope Research Institute Glendale Arizona
GI Research Associates, LLC Phoenix Arizona
"Forty-Third Medical Associates Absolute Clinical Research" Phoenix Arizona
Del Sol Research Management, LLC Tucson Arizona
Novak Clinical Research Tucson Arizona
Del Sol Research Management, LLC Tuscon Arizona
Preferred Research Partners, Inc Little Rock Arkansas
Premier Gastroenterology Little Rock Arkansas
Arkansas Gastroenterology North Little Rock Arkansas
Associated Gastroenterology Medical Group Anaheim California
InSite Digestive Health Care Arcadia California
Gastroenterology Burlingame California
Ventura County Gastroenterology Medical Group Camarillo California
Hope Clinical Research Canoga Park California
Alliance Research Institute Canoga Park California
Gastro SB Clinic Chula Vista California
Precision Research Institute Chula Vista California
BG Clinical Research and affiliate of The Clinical Trials Network, LLC Encinitas California
Diagnamics, Inc Encinitas California
Helping Hands Healthcare Group Fullerton California
Paragon RX Clinical, Inc. Garden Grove California
Digestive Health Research of Southern California Huntington Beach California
United Medical Doctors Irvine California
Gastro Care Institute Lancaster California
LA Gastroenterology Group Los Angeles California
University of Southern California Los Angeles California
Gastroenterology Associates of Beverly Hills Los Angeles California
Knowledge Research Center Orange California
InSite Digestive Health Care-San Gabriel Oxnard California
Desert Oasis Healthcare Medical Group Palm Springs California
Palm Tree Clinical, Inc Palm Springs California
InSite Digestive Health Care - Gastroenterology Associates Pasadena California
Northern California Research Sacramento California

+ 231 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04136002 on ClinicalTrials.gov ↗ ← All trials in the USA