Clinical trial · Observational
Head to Head Study Epi proColon and FIT
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
NCT01580540CI-TRIAL-00018751completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Group A, subjects with colorectal cancer
- description
- 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.
- label
- Group B, subjects without CRC
- description
- Subjects between ages 50 and 84 who provide stool and blood specimens prior to colonoscopy.
Primary outcomes (1)
- 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.
- timeFrame
- At completion of testing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 84 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJohnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014. PMID 24901436