Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode
45 - 84 Years, Male and Female
02-GI-002 (primary)
NCI-2021-00076
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.
Objectives
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.
Eligibility
- 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
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