Trial document
DRKS00004305
Trial Description
Title
Retro- and prospective observational study evaluating MSI and KRAS for prognosis of early colorectal cancer stage I, II and III
Trial Acronym
ColoPredict Plus 2.0 Register
URL of the Trial
[---]*
Brief Summary in Lay Language
Colopredict Plus 2.0 molecular registry captures clinical data, blood and tissue of patients with colon cancer (CC) stages I, II and III retro- and prospectively over a period of 5 years after primary diagnosis. Primary objective is the evaluation of microsatellite instability (MSI) combined with KRASmutations regarding the prognosis of CC stage II without clinical risk factors. Next to an analysis of MSI and KRAS in the resected CC tissue samples, clinical and histopathological data are being captured. Primary objective is the recurrence free survival (RFS) after 5 years (combined: CC recurrence or death of any cause).
Brief Summary in Scientific Language
Identification of a marker panel for therapy in CRC
Do you plan to share individual participant data with other researchers?
Yes
Description IPD sharing plan:
On request our study may serve as screening platform for other Trials.
Organizational Data
- DRKS00004305
- 2013/01/09
- [---]*
- yes
- Approved
- 4449-12, 6151-17, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
Secondary IDs
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Health Condition or Problem studied
- C18 - Malignant neoplasm of colon
Interventions/Observational Groups
-
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 relevant histopathological and clinical data.
Characteristics
- Non-interventional
- Epidemiological study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Prognosis
- Single (group)
- N/A
- N/A
Primary Outcome
5-year RFS of MSI/KRAS WT patients versus MSS/KRAS MT patients with colon cancer stage II without risk factors
Secondary Outcome
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
Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Actual
- 2013/09/01
- 8000
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional 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
Addresses
-
start of 1:1-Block address primary-sponsor
- Institut für Pathologie der Ruhr-Universität Bochum
- Ms. Prof. Dr. med. Andrea Tannapfel
- Bürkle-de-la-Camp-Platz 1
- 44789 Bochum
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0234 302 4800
- 0234 302 4809
- Andrea.tannapfel at rub.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Institut für Pathologie
- Ms. Professor Andrea Tannapfel
- Bürkle-de-la-Camp-Platz 1
- 44789 Bochum
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 234 302 4800
- +49 234 302 4899
- andrea.tannapfel at rub.de
- http://www.pathologie-bochum.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Institut für Pathologie
- Ms. Prof. Dr. med. Andrea Tannapfel
- Bürkle-de-la-camp Platz 1
- 44789 Bochum
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0234 302 4800
- 0234 302 4899
- andrea.tannapfel at rub.de
- http://www.pathologie-bochum.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Institut für Pathologie
- Ms. Prof. Dr. med. Andrea Tannapfel
- Bürkle-de-la-Camp-Platz 1
- 44789 Bochum
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- DE 0234 302 4800
- DE 0234 302 4809
- andrea.tannapfel at rub.de
- http://www.pathologie-bochum.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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