Trial document




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  DRKS00004305

Trial Description

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Title

retro- and prospective evaluation of the role of MSI and KRAS for the prognosis of colonic cancer stage II and III

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Trial Acronym

ColoPredict Register

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URL of the Trial

[---]*

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Brief Summary in Lay Language

There will be prospective evaluation of colonic cancer patients state II and III - MSI and KRAS will be evaluated as taking part of prospective factors for therapy.
Primary target is the role of microsatellite instability combined with mutated KRAS-status in colorectal cancer stage II without risk factors. KRAS and MSI will be determined in tumor tissue of the recruited patients and clinical /histopathological Data will be documented. Primary targeting parameter is progression-free survival after 5 years of observation.

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Brief Summary in Scientific Language

Identification of a marker panel for therapy in CRC

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Organizational Data

  •   DRKS00004305
  •   2013/01/09
  •   [---]*
  •   yes
  •   Approved
  •   4449-12, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
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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 KRAS, and we will collect relevant histopathological and clinical data.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

progression-free survival of patients with MSI/KRAS wildtype versus patients with MSS/KRAS mutated colonic cancer stage II without risk factors in the 5-year intervall

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Secondary Outcome

progression-free survival of patients with MSI/KRAS wildtype versus patients with MSS/KRAS mutated colonic cancer stage II with risk factors in the 5-year intervall;

5-year-intervall OS ( Overall survival), DFS ( Disease-free survival) in stage II, RFS ( relapse-free survival), DFS and OS in stage III,

identification of a prognostic signature for patients in stage II w/o RF ( Risk-factors)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2013/09/01
  •   3331
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients (male or female) diagnosed colonic cancer stage II or III
tumor and healthy tissue available
recommendations according GCP ( ≥ 18Years, given consent, intellectual format for understanding
medical confidentiality towards study-specific matters must be nullified

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Exclusion Criteria

patients not fulfilling inclusion criteria
patients refusing their consent

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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
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    • Institut für Pathologie
    • Ms.  Professor  Andrea  Tannapfel 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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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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Sources of Monetary or Material Support

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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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Status

  •   Recruiting ongoing
  •   [---]*
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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.