Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011793

Trial Description

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Title

Colorectal cancer: chances for prevention through screening

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Trial Acronym

DACHS

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URL of the Trial

http://www.dachsstudie.de

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Brief Summary in Lay Language

The DACHS study is an epidemiological of the German Cancer Research Center (DKFZ). DACHS is an abbreviation for "Darmkrebs: Chancen der Verhütung durch Screening" (Colorectal cancer: chances for prevention through screening).

Since 2003, we have been recruiting colorectal cancer patients and randomly selected control participants with no history of colorectal cancer for this study. The control participants and patients are matched with respect to age, sex, and their county of residence. Patients are followed up for 10 years to assess the course of their disease.

With the DACHS study, we want to make a substantial contribution to the improvement of colorectal cancer prevention and prognosis.

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Brief Summary in Scientific Language

Epidemiological case-control study on colorectal cancer with long-term follow-up of colorectal cancer patients for the investigations on colorectal cancer prevention and prognosis.

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Organizational Data

  •   DRKS00011793
  •   2017/03/06
  •   2016/03/23
  •   yes
  •   Approved
  •   310/2001, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   ST-D-066  (Studybox)
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Colorectal cancer patients: interview, blood sample collection, tumor tissue sample collection, medical records
  •   Control participants with no colorectal cancer: interview (if denied, offer of self-administered questionnaire), blood sample collection, medical records
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1) At what age should the first screening examination take place?
2) What time intervals between screening examinations (notably screening endoscopy) are reasonable?
3) Should there be different screening intervals for different risk groups?

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Secondary Outcome

Role of risk and prognostic factors with respect to colorectal cancer risk and survival after colorectal cancer, respectively.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2003/01/01
  •   16000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Colorectal cancer patients and control participants with no colorectal cancer: first residency in study region, good knowledge of German language, capable to participate (interview approx. 1 h), written informed consent

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Exclusion Criteria

Cases: if not a first diagnosis; controls: previous diagnosis of colorectal cancer

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Addresses

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    • Deutsches Krebsforschungszentrum (DKFZ), Abteilung Klinische Epidemiologie und Alternsforschung
    • Mr.  Prof. Dr.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum (DKFZ), Abteilung Klinische Epidemiologie und Alternsforschung
    • Mr.  Prof. Dr.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum (DKFZ), Abteilung Klinische Epidemiologie und Alternsforschung
    • Mr.  PD Dr.  Michael  Hoffmeister 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum (DKFZ), Abteilung Epidemiologie von Krebserkrankungen
    • Ms.  Prof. Dr.  Jenny  Chang-Claude 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum (DKFZ)Abteilung Klinische Epidemiologie und Alternsforschung
    • Ms.  Ute  Handte-Daub 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • 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.