Trial document





This trial has been registered retrospectively.
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  DRKS00000017

Trial Description

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Title

Evaluation of biomarkers indicating fibrotic activity in idiopathic pulmonary fibrosis and other diffuse parenchymal lung diseases.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of potential biomarkers in a cohort of patients with pulmonary fibrosis regarding survival and course of pulmonary function test. Evaluation of potential biomarker expression in non fibrotic lung diseases such as COPD and healthy volunteers will be performed.

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Brief Summary in Scientific Language

Evaluation of CCL18 and other potential biomarkers in a cohort of patients with pulmonary fibrosis (n=100) regarding survival and course of pulmonary function test. Evaluation of biomarker expression in non fibrotic lung diseases such as COPD (n=100) and healthy volunteers (n=200)will be analyzed.

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Organizational Data

  •   DRKS00000017
  •   2008/09/05
  •   2006/09/15
  •   yes
  •   Approved
  •   047/06, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   UKF000834  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   J84 -  Other interstitial pulmonary diseases
  •   J43 -  Emphysema
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Interventions/Observational Groups

  •   Evaluation of biomarkers after blood sample collection
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Diagnostic
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Survival, Change in FVC percent predicted (> 10%), Change in TLC percent predicted (> 10%),

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Secondary Outcome

Changes in 6 min shuttle walk test, DLCO.

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Countries of Recruitment

  •   Germany
  •   Italy
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2006/03/11
  •   400
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Patients with IPF, COPD, Bronchiolitis obliterans Syndrome, Patients with other ILDs, Healthy Volunteers

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Exclusion Criteria

known tumor disease
known aktive infection

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Addresses

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    • Abteilung für Pneumologie
    • Antje  Prasse 
    • Kilianstrasse 5
    • 79106   Freiburg
    • Germany
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    •   0761 2703720
    •   0761 2703704
    •   [---]*
    •   [---]*
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    • Abteilung für Pneumologie Universitätsklinikum Freiburg
    • Ms.  PD Dr. med.  Antje  Prasse 
    • Kilianstarsse 5
    • 79106   Freiburg
    • Germany
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    • Abteilung für Pneumologie
    • PD Dr. med.  Antje   Prasse 
    • Kilianstrasse 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Pneumologie Universitätsklinikum Freiburg
    • Ms.  PD Dr. med.  Antje  Prasse 
    • Kilianstarsse 5
    • 79106   Freiburg
    • 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.