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

Running, not enrolling

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04136002

Run by

Guardant Health, Inc.

People needed

44467

Starts

2019-10-08

Expected to finish

2027-08-05

Last updated by the study team

2026-05-14

Who can join

Age: 45 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• 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

Where it is running

• Lakeview Clinical Research — Guntersville, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• Jasper Summit Research LLC — Jasper, Alabama, United States
• Hope Research Institute — Chandler, Arizona, United States
• Southeast Valley Gastroenterology — Chandler, Arizona, United States
• Prime Medical Group, LLC — Gilbert, Arizona, United States
• Hope Research Institute — Glendale, Arizona, United States
• GI Research Associates, LLC — Phoenix, Arizona, United States
• "Forty-Third Medical Associates Absolute Clinical Research" — Phoenix, Arizona, United States
• Del Sol Research Management, LLC — Tucson, Arizona, United States
• Novak Clinical Research — Tucson, Arizona, United States
• Del Sol Research Management, LLC — Tuscon, Arizona, United States
• Preferred Research Partners, Inc — Little Rock, Arkansas, United States
• Premier Gastroenterology — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Associated Gastroenterology Medical Group — Anaheim, California, United States
• InSite Digestive Health Care — Arcadia, California, United States
• Gastroenterology — Burlingame, California, United States
• Ventura County Gastroenterology Medical Group — Camarillo, California, United States
• Hope Clinical Research — Canoga Park, California, United States
• Alliance Research Institute — Canoga Park, California, United States
• Gastro SB Clinic — Chula Vista, California, United States
• Precision Research Institute — Chula Vista, California, United States
• BG Clinical Research and affiliate of The Clinical Trials Network, LLC — Encinitas, California, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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