Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000829

Trial Description

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Title

Barrett's Sports Study

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Trial Acronym

[---]*

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URL of the Trial

http://keine

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Brief Summary in Lay Language

In the present study, the impact of sports on reflux disease and Barretts esophagus with or without neoplastic changes is evaluated. Several groups of patients fill in a questionnaire on their sports activity during every day life. The sports activity is by this evaluated in patients with reflux disease, with Barretts esophagus without neoplastic chances, with Barretts transformed to malignancy, and in patients with various other diseases of the upper gastrointestinal tract. The aim of the present study is to find out wheter sports may pose a protective factor against Barretts esophagus and especially its malignant transformation. In order to evaluate this, the different sports activities in the four groups will be compared at the end of the study.

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Brief Summary in Scientific Language

Data are registered in a prospective database using a anonymous questionnaire that deals with the impact of sports on reflux disease and Barretts esophagus; trial comparing controls with other diseases of the upper GI tract, reflux disease patients, Barretts patients without neoplasia, Barretts patients with neoplasia

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Organizational Data

  •   DRKS00000829
  •   2011/05/30
  •   [---]*
  •   yes
  •   Approved
  •   FF106/2010, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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

  •   K22.7 -  Barrett's oesophagus
  •   K21.0 -  Gastro-oesophageal reflux disease with oesophagitis
  •   R12 -  Heartburn
  •   C15.5 -  Malignant neoplasm: Lower third of oesophagus
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Interventions/Observational Groups

  •   All participating patients fill in the same questionnaire on their sports activity

    Patients with reflux disease without Barretts esophagus
  •   All participating patients fill in the same questionnaire on their sports activity

    Patients with Barretts esophagus without neoplasia
  •   All participating patients fill in the same questionnaire on their sports activity

    Patients with Barretts esophagus with neoplasia
  •   All participating patients fill in the same questionnaire on their sports activity

    Patients with other diseases of the upper GI tract
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Characteristics

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

Intensity of sports activity according to a newly developed sports score

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Secondary Outcome

Evaluation of various further factors leading to arisal of neoplasia in Barretts esophagus

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/04/19
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   75   Years
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Additional Inclusion Criteria

one of the four diagnoses:
Reflux disease,
Barretts esophagus without neoplasia,
Barretts esophagus with neoplasia,
other disease of upper GI tract

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Exclusion Criteria

patient not able to fill out questionnaire

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HSK Wiesbaden
    • Mr.  Prof.   C.  Ell 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • HSK Wiesbaden
    • Mr.  PD  Hendrik  Manner 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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    • HSK Wiesbaden
    • Mr.  PD  Hendrik  Manner 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • Stiftung Leben mit Krebs
    • Postfach 1852
    • 61288  Bad Homburg v.d.H.
    • 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.