Molecular stool testing for colorectal cancer surveillance

• Conditions: colorectal cancer, surveillance, molecular stool testingcolorectaal carcinoom, surveillance, moleculaire ontlastingstest

• Registration Number: NL-OMON26772
• Lead Sponsor: prof. dr. P. FockensMeibergdreef 9, room C2-3301105 AZ Amsterdam, the Netherlandsemail: p.fockens@amc.uva.nltel: +31 20 5663408

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 4000

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.

Exclusion Criteria

Amendment 3-jun-2016:
- Subjects with inflammatory bowel disease (IBD)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br /><br>2. Health outcomes and cost-effectiveness of multiple surveillance strategies based on accuracies from endpoint 1.

Secondary Outcome Measures

Name	Time	Method
- The presence of the molecular markers (included in the molecular stool test) in the resected polyps;<br /><br>- The correlation between the presence of the molecular markers and the result of the molecular stool test;<br /><br>- The identification of low- and high risk adenomas based on previously identified progression biomarkers in all the post-polypectomy tissue samples;<br /><br>- The impact of molecularly defined high-risk adenoma’s on the obtained sensitivity data of the molecular stool test (Cologuard®) and FIT;<br /><br>- The impact of the integration of molecularly defined high-risk adenoma’s on the health outcomes and cost-effectiveness of the multiple surveillance strategies.<br /><br>- 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.