colorectal cancer, surveillance, molecular stool testing colorectaal carcinoom, surveillance, moleculaire ontlastingstest
Conditions
Interventions
Collection of whole-stool samples for stool testing primary to surveillance colonoscopy and the completion of a questionnaire.
Sponsors
prof. dr. P. Fockens
Meibergdreef 9, room C2-330
1105 AZ Amsterdam, the Netherlands
email: p.fockens@amc.uva.nl
tel: +31 20 5663408
Eligibility
Inclusion criteria
Inclusion criteria: Amendment 3-jun-2016: - Subjects in the age group 50-75 years. The lower age limit is set at 50 years because of the high probability of familiar predisposition when advanced neoplasm is present in a younger age group.26 The upper age limit of 75 years is in correspondence with the recommended stop-age for surveillance according to the current guideline. - 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, including 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
Exclusion criteria: Amendment 3-jun-2016: - 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) - Previous colonoscopy < 6 months (rescopy) - Subjects with proctocolectomy - Subjects with life expectancy < 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The accuracy (sensitivity, specificity, PPV and NPV) of the molecular stool test (Cologuard®) and FIT compared to colonoscopy in the detection of advanced neoplasia in a surveillance population. 2. Health outcomes and cost-effectiveness of multiple surveillance strategies based on accuracies from endpoint 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The presence of the molecular markers (included in the molecular stool test) in the resected polyps; - The correlation between the presence of the molecular markers and the result of the molecular stool test; - The identification of low- and high risk adenomas based on previously identified progression biomarkers in all the post-polypectomy tissue samples; - The impact of molecularly defined high-risk adenoma’s on the obtained sensitivity data of the molecular stool test (Cologuard®) and FIT; - The impact of the integration of molecularly defined high-risk adenoma’s on the health outcomes and cost-effectiveness of the multiple surveillance strategies. - The additional value of risk assessment through a questionnaire (addressing gender, age, BMI20,21, family history22,23, physical activity, nutritional habits and smoking) on the accuracy of the molecular stool test (Cologuard®) and FIT. | — |
Contacts
Public ContactMCJ van Lanschot
Meibergdreef 9, room B1-245
Outcome results
None listed