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

Status
Active
Cancer Type
Colon/Rectal Cancer
Trial Phase
Eligibility
45 - 84 Years, Male and Female
Study Type
Other
NCT ID
NCT04136002
Protocol IDs
02-GI-002 (primary)
NCI-2021-00076
Study Sponsor
Guardant Health Inc

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

  1. Subjects aged 45-84 years at time of consent
  2. Intended to undergo screening colonoscopy
  3. Considered by a physician or healthcare provider as being of 'average risk' for CRC
  4. 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
  5. Willing to consent to follow-up for two years as per protocol
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.