Evaluation of the ctDNA LUNAR-2 Test In an Average Patient Screening Episode (ECLIPSE).

Abstract

TPS142 Background: Population-wide colorectal cancer (CRC) screening has been recommended by the United States Preventive Task Force (USPSTF) since 2008. Despite multiple CRC screening options, screening compliance rates have plateaued well below the 80% compliance goal set by leading health organizations. Almost 1 in 3 Americans are non-compliant with screening recommendations, citing reasons that screening is time consuming, unpleasant, and in the case of colonoscopy, invasive. The potential exists for a blood-based CRC screening test with high sensitivity and specificity to improve uptake and adherence to CRC screening. Methods: ECLIPSE (Evaluation of the ctDNA LUNAR-2 Test In an Average Patient Screening Episode; NCT# 04136002) is a prospective, observational, multi-center study being conducted in the United States. The primary objective is performance of a proprietary blood-based circulating tumor DNA (ctDNA) test (LUNAR-2, Guardant Health, Redwood City, CA) developed to detect CRC in a screen-relevant, average risk population as compared to colonoscopy reference. ECLIPSE involves collection of whole blood prior to a standard of care screening colonoscopy and associated preparation from 10,000 subjects. Eligibility criteria include average risk adults age 45-84 without prior history of cancer, inflammatory bowel disease, or familial predisposition to CRC, and have not received recent CRC screening. Primary outcomes are sensitivity of CRC detection and specificity of advanced neoplasia (AN) detection. Health-related outcomes at one and two-years will be collected as secondary endpoints to investigate the possibility of incidental non-CRC cases and interval CRC cases that had not reached a clinical threshold for detection at time of colonoscopy. Additional secondary objectives are positive predictive value and negative predictive value for AN detection and sensitivity of advanced adenoma detection. Enrollment began in October 2019, continues at over 130 sites nationwide, and is on track for the 24-month enrollment goal. Study enrollment remained open despite the COVID-19 pandemic. Study features including mobile phlebotomy and remote site monitoring were implemented. This contributed to successful study execution during COVID-19, as demonstrated by the enrollment rebound observed as early as June 2020 which saw higher enrollment than prior months, even pre-COVID. Clinical trial information: NCT# 04136002.