NCT04136002

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44,467 (actual)
• Sponsor: Guardant Health, Inc. · Industry
• Sex: All
• Age: 45 Years – 84 Years
• Healthy volunteers: Accepted

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.

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. 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.

Conditions

• Colorectal Cancer

Timeline

• Start date: 2019-10-08
• Primary completion: 2024-03-20
• Completion: 2025-08-05
• First posted: 2019-10-23
• Last updated: 2025-08-11

Locations

271 sites across 1 country: United States