Trial document

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DRKS-ID: DRKS00004305

Trial Description

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Title

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

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Trial Acronym

ColoPredict Plus 2.0 Register

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URL of the Trial

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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).

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Brief Summary in Scientific Language

Identification of a marker panel for therapy in CRC

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

On request our study may serve as screening platform for other Trials.

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Organizational Data

DRKS-ID: DRKS00004305
Date of Registration in DRKS: 2013/01/09
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 4449-12, 6151-17, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum

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Secondary IDs

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Health Condition or Problem studied

ICD10: C18 - Malignant neoplasm of colon

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Interventions/Observational Groups

Arm 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 relevant histopathological and clinical data.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Epidemiological study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Prognosis
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

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

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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

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2013/09/01
Target Sample Size: 8000
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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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

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Exclusion Criteria

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

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Addresses

Primary Sponsor
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- Institut für Pathologie der Ruhr-Universität Bochum
- Ms. Prof. Dr. med. Andrea Tannapfel
- Bürkle-de-la-Camp-Platz 1
- 44789 Bochum
- Germany
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- Telephone: 0234 302 4800
- Fax: 0234 302 4809
- E-mail: Andrea.tannapfel at rub.de
- URL: [---]*
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Contact for Scientific Queries
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- Institut für Pathologie
- Ms. Professor Andrea Tannapfel
- Bürkle-de-la-Camp-Platz 1
- 44789 Bochum
- Germany
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- Telephone: +49 234 302 4800
- Fax: +49 234 302 4899
- E-mail: andrea.tannapfel at rub.de
- URL: http://www.pathologie-bochum.de
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Contact for Public Queries
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- Institut für Pathologie
- Ms. Prof. Dr. med. Andrea Tannapfel
- Bürkle-de-la-camp Platz 1
- 44789 Bochum
- Germany
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- Telephone: 0234 302 4800
- Fax: 0234 302 4899
- E-mail: andrea.tannapfel at rub.de
- URL: http://www.pathologie-bochum.de
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Institut für Pathologie
- Ms. Prof. Dr. med. Andrea Tannapfel
- Bürkle-de-la-Camp-Platz 1
- 44789 Bochum
- Germany
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- Telephone: DE 0234 302 4800
- Fax: DE 0234 302 4809
- E-mail: andrea.tannapfel at rub.de
- URL: http://www.pathologie-bochum.de
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Status

Recruitment Status: Recruiting ongoing
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: [---]*
Total Number of Participants (all Sites worldwide) after Recruiting complete: [---]*

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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.