Biobank for development of screening markers for colorectal neoplasia. Translational research in colorectal cancer and adenomas.
Recruiting
- Conditions
- Coloncancer. Large polyps.10017990
- Registration Number
- NL-OMON37786
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3500
Inclusion Criteria
All subjects 40 years of age or older scheduled for colonoscopy will be invited to participate. Subjects with colorectalcancer (CRC) or advanced adenomas detected at colonoscopy will be included as cases, whereas subjects without advanced neoplasia will be included as controls.
All subjects should be capable to give informed consent. All subjects should speak and understand the Dutch language
Exclusion Criteria
- Subjects < 40 years of age
- No informed consent
- Subjects with IBD/sigmoidoscopy or colonoscopy in the past four weeks/extended hemicolectomie/colostomy
- Subjects who received chemotherapy in the past three weeks
- Hospitalized individuals
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Collection of faeces for development and improvement of new biomarkers for CRC.<br /><br>Development of a stool test with a (panel of) molecular marker(s).<br /><br>Endpoints for evaluation of screening markers: presence of CRC and advanced<br /><br>adenomas (advanced neoplasia).<br /><br><br /><br>The following test characteristics are used as primary outcome measurements for<br /><br>the different biomarkers.<br /><br>- Sensitivity<br /><br>- Specificity<br /><br>- Positive predictive value (PPV)<br /><br>- Negative predictive value (NPV)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality and stability of samples collected.</p><br>