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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

50 Years
84 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

Observational Model: Case Control

Outcome Measure:

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.

Outcome Time Frame:

At completion of testing.

Safety Issue:


Principal Investigator

Juergen Beck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Epigenomics, Inc


United States: Institutional Review Board

Study ID:

Epigenomics-SPR 0022



Start Date:

March 2012

Completion Date:

November 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms



Ochsner Clinic Foundation New Orleans, Louisiana  70121
Middlesex Hospital Cancer Center Middletown, Connecticut  06457
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Carolina Digestive Health Associates Harrisburg, North Carolina  28075
Beaumont Hospital Royal Oak, Michigan  48073
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Digestive and Liver Disease Specialists Norfolk, Virginia  23502
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