Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode (ECLIPSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04136002|
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : January 27, 2020
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode|
|Actual Study Start Date :||October 8, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2024|
- Sensitivity of colorectal cancer detection [ Time Frame: 60 days ]
- Specificity of advanced neoplasia detection [ Time Frame: 60 days ]
- Positive predictive value of colorectal cancer detection [ Time Frame: 60 days ]
- Negative predictive value of colorectal cancer detection [ Time Frame: 60 days ]
- Sensitivity and specificity of advanced adenoma detection [ Time Frame: 60 days ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136002
|Contact: Linda Higashi||650-503-1814||ECLIPSE@guardanthealth.com|
|Contact: Guilnor Afalla Placido||650-503-1814||ECLIPSE@guardanthealth.com|
|Principal Investigator:||Kathryn Lang, MBBS MRCP||GUARDANT HEALTH|