Retro- and prospective observational study evaluating MSI and KRAS for prognosis of early colorectal cancer stage I, II and III
Recruiting
- Conditions
- C18Malignant neoplasm of colon
- Registration Number
- DRKS00004305
- Lead Sponsor
- Institut für Pathologie der Ruhr-Universität Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients, treated at participating sites are eligible for participation if they fulfill all oft he following criteria:
prospective enrollment:
• Male or female patient with CC UICC stage I, II or III
• Cooperating pathology willing to provide tissue samples for research according to study protocol
• Age = 18 years and able to understand the concept of the registry and give informed consent
• signed informed consent for registry participation according to ICH-GCP guidelines
retrospective enrollment:
• primary diagnosis since 1st January 2006
• other inclusion criteria according to protocoll version 5.1.1
Exclusion Criteria
patients that
• do not fulfill inclusion criteria
• withdraw consent to participate
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year RFS of MSI/KRAS WT patients versus MSS/KRAS MT patients with colon cancer stage II without risk factors
- Secondary Outcome Measures
Name Time Method 5-year RFS of MSI/KRAS WT patients versus MSS/KRAS MT patients with colon cancer stage II with risk factors<br>OS, DFS of patients with colon cancer stage II<br>RFS, DFS and OS of patients with colon cancer stage III <br><br>explorative:<br>Identify molecular signature for patients stage II without risk factors<br>To identify patients that are clinically and/or molecularly eligible for interventional trials (optional).<br>establish a participatory decision making strategy