Trial document




drksid header

  DRKS00004305

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ColoPredict Plus 2.0 Register

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Identification of a marker panel for therapy in CRC

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

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

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004305
  •   2013/01/09
  •   [---]*
  •   yes
  •   Approved
  •   4449-12, 6151-17, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/09/01
  •   8000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

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-sponsor
    start of 1:1-Block address contact primary-sponsor
    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-contact
    start of 1:1-Block address contact scientific-contact
    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-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

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 materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.