MOlecular stool testing for Colorectal CAncer Surveillance

Completed

Conditions: colorectal carcinoma
colorectal neoplasia
10017990

Registration Number: NL-OMON50418

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4000

Inclusion Criteria

- Subjects in the age group 50-75 years.
- Subjects with an indication for surveillance colonoscopy according to the
previous guideline (*Follow up after polypectomy*, 2002; summarized in 2008) or
current (*Colonoscopy Surveillance*, 2013) guideline, i.e. subjects with a
history of CRC or polypectomy, as well as subjects under surveillance for
familial colorectal carcinoma (FCC).
- Subjects who have sufficient comprehension of the Dutch language.
- Subjects who have given their informed consent.

Exclusion Criteria

- Subjects with inflammatory bowel disease (IBD)
- Subjects with Lynch syndrome, familial adenomatous polyposis (FAP),
attenuated FAP (AFAP), MUTYH associated polyposis (MAP) and serrated polyposis
syndrome (SPS)
- Subjects with a previous colonoscopy < 6 months (rescopy)
- Subjects with proctocolectomy
- Subjects with life expectancy < 3 years

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The accuracy (sensitivity, specificity, PPV and NPV) of the molecular stool<br /><br>test (Cologuard®) and FIT compared to colonoscopy in the detection of advanced<br /><br>neoplasia compared in a surveillance population.<br /><br>2. Health outcomes and cost-effectivess of multiple surveillance strategies<br /><br>based on accuracies from endpoint 1. </p><br>

Secondary Outcome Measures