Trial document



drksid header

  DRKS00004305

Trial Description

start of 1:1-Block title

Title

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

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

Trial Acronym

ColoPredict 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

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.

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 organizational data

Organizational Data

  •   DRKS00004305
  •   2013/01/09
  •   [---]*
  •   yes
  •   Approved
  •   4449-12, 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 KRAS, 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

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

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

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)

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
  •   3331
  •   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 (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

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

Exclusion Criteria

patients not fulfilling inclusion criteria
patients refusing their consent

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.