Head to Head Study Epi proColon and FIT

Study Overview
=================
Brief Summary
-----------------
The study aims to show non-inferiority in the clinical performance of the investigational assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline eligible subjects.

Detailed Description
-----------------
There is strong evidence supporting the use of FOBT in CRC screening, with the earliest randomized controlled trials demonstrating a reduction in CRC incidence and mortality from CRC screening. Despite the implementation and incremental improvements in gFOBT- and FIT-based tests, they continue to represent a small percentage of CRC screening and currently remain largely the province of large, integrated healthcare delivery systems. Reasons for the limited adoption of stool-based testing are complicated, but include lack of physician recommendation, patient preferences, and cultural barriers. Availability of a blood-based test may overcome the adoption challenges presently facing stool-based CRC screening and facilitate better compliance with CRC screening guidelines. However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC in a blood sample. As such, a high through-put blood-based test with performance characteristics similar to fecal testing could satisfy this clinical need. This study is designed to prospectively collect matched blood and stool specimens and clinical data from screening guideline-eligible subjects found to have invasive colorectal cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of specimens and testing after colonoscopy and from screening guideline-eligible subjects with blood and stool specimens collected before colonoscopy. A completed subject will have a FIT result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical status (CRC, non-CRC). Demographic and baseline covariates will be reported for each individual.

Official Title
-----------------
Comparison of the Performance of the Epi proColon and Fecal ImmunochemicalTest Post Colonoscopy in Subjects With Colorectal Cancer and Pre Colonoscopy in Subjects From a Guideline-Eligible Screening Population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group A Willing and able to sign an informed consent and adhere to study requirements 50 - 84 years of age at blood and stool sampling Colonoscopic diagnosis of colorectal carcinoma Colonoscopy within 6 months before inclusion into study Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery Group B Willing and able to sign an informed consent and adhere to study requirements 50 - 84 years of age at blood and stool sampling Able to provide blood and stool sample prior to bowel prep and colonoscopy Exclusion Criteria: Group A Subject with curative biopsy during colonoscopy Group A and B Previous personal history of CRC or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years Neoadjuvant treatment Familial risk for colorectal cancer History of inflammatory bowel disease Acute or chronic gastritis Current diagnosis of any other cancer Overt rectal bleeding or bleeding hemorrhoids Known infection with HIV, HBV, or HCV Subject concurrently receiving intravenous fluid at the time of the sample collection

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 84 Years

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

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

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A, subjects with colorectal cancer<br>Subjects between ages 50 and 84 identified to have CRC. Blood and stool specimens are collected and tested after colonoscopy and prior to surgery or other interventions. | |
| Group B, subjects without CRC<br>Subjects between ages 50 and 84 who provide stool and blood specimens prior to colonoscopy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of Epi proColon test result compared to FIT result using a 95% confidence interval for difference in sensitivities and differences in specificities below a strictly defined margin. |  | At completion of testing. |