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

Active:	No
Cancer Type:	Colon/Rectal Cancer	NCT ID:	NCT04136002
Trial Phases:		Protocol IDs:	02-GI-002 (primary) NCI-2021-00076
Eligibility:	45 - 84 Years, Male and Female	Study Type:	Other
Study Sponsor:	Guardant Health, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04136002

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.

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