Status:
COMPLETED
Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode
Lead Sponsor:
Guardant Health, Inc.
Collaborating Sponsors:
Premier Research
Conditions:
Colorectal Cancer
Eligibility:
All Genders
45-84 years
Brief 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 stud...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 5 2025
Estimated Enrollment :
44467 Patients enrolled
Trial Details
Trial ID
NCT04136002
Start Date
October 8 2019
End Date
August 5 2025
Last Update
August 11 2025
Active Locations (271)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Lakeview Clinical Research
Guntersville, Alabama, United States, 35976
3
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
4
Jasper Summit Research LLC
Jasper, Alabama, United States, 35501