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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 45-84 years at time of consent Intended to undergo screening colonoscopy Considered by a physician or healthcare provider as being of 'average risk' for CRC 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 Willing to consent to follow-up for two years as per protocol Exclusion Criteria: Undergoing colonoscopy for investigation of symptoms Has undergone colonoscopy within preceding 9 years Positive FIT/FOBT result within the previous 6 months Has completed Cologuard or Epi proColon testing within the previous 3 years History of colorectal cancer History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study) Known diagnosis of inflammatory bowel disease Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs) Positive family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC [HNPCC], or Familial Adenomatous Polyposis [FAP]) Any major physical trauma (e.g. disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of colorectal cancer detection | Sensitivity of colorectal cancer detection | 60 days | 
| Specificity of advanced neoplasia detection | Specificity of advanced neoplasia detection | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of colorectal cancer detection | Positive predictive value of colorectal cancer detection | 60 days | 
| Negative predictive value of colorectal cancer detection | Negative predictive value of colorectal cancer detection | 60 days | 
| Sensitivity and specificity of advanced adenoma detection | Sensitivity and specificity of advanced adenoma detection | 60 days |