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Retro- and prospective observational study evaluating MSI and KRAS for prognosis of early colorectal cancer stage I, II and III

Retro- and prospective observational study evaluating MSI and KRAS for prognosis of early colorectal cancer stage I, II and III - ColoPredict Plus 2.0 Register

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00004305
Enrollment
Unknown
Registered
2013-01-09
Start date
2013-09-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C18

Interventions

Group 1: Each Patient will be treated according to his physicians therapeutic strategy - there is no intervention and no arming. Tumor tissue will be tested for MSI and RAS, and we will collect releva

Sponsors

Institut für Pathologie der Ruhr-Universität Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: patients that • do not fulfill inclusion criteria • withdraw consent to participate

Design outcomes

Secondary

MeasureTime frame
5-year RFS of MSI/KRAS WT patients versus MSS/KRAS MT patients with colon cancer stage II with risk factors OS, DFS of patients with colon cancer stage II RFS, DFS and OS of patients with colon cancer stage III explorative: Identify molecular signature for patients stage II without risk factors To identify patients that are clinically and/or molecularly eligible for interventional trials (optional). establish a participatory decision making strategy

Primary

MeasureTime frame
5-year RFS of MSI/KRAS WT patients versus MSS/KRAS MT patients with colon cancer stage II without risk factors

Countries

Germany

Contacts

Public ContactAndrea Tannapfel

Institut für Pathologie

andrea.tannapfel@rub.de0234 302 4800

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026