Trial document




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  DRKS00008196

Trial Description

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Title

Prospective registry study investigating medical care in hematooncologic patients with venous
thromboembolism in Berlin

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Trial Acronym

GECAT – German Evaluation of Cancer associated Thrombosis

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URL of the Trial

http://keine

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Brief Summary in Lay Language

About 300 patients with new diagnosis of venous thrombembolism who recieve inpatient or outpatient treatment in the hospitals of charite Berlin or Vivantes GmbH Berlin shall be included in the study. If a malignant disease is known or newly diagnosed, the patient will be observed for further six months follow-up time. Patients without malignant disease are evaluated once and do not take part in follow-up.
Aim of the study is to evaluate diagnostic procedures and treatment of patients suffering venous thrombembolism and malignant disease (without interventional therapy) for a period of 6 months

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Brief Summary in Scientific Language

In this prospective registry study treatment and medical care of 300 patients with malignant diseases and venous thromboembolism shall be documented over a period of 6 months after diagnosis of thromboembolism.
Primary aim in the context of health care research is the documentation of the actual clinical practice of the treatment of these patients.
There will be no interventions in the treatment of the patients, e.g. no specifications of diagnostic methods or therapy.
By means of this registry study it will be possible for the first time to collect data on the patients’ medical history/career and medical pathways.

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Organizational Data

  •   DRKS00008196
  •   2015/05/18
  •   [---]*
  •   yes
  •   Approved
  •   Eth-03/15, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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

  •   I80.9 -  Phlebitis and thrombophlebitis of unspecified site
  •   C00-C75 -  Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
  •   I80.0 -  Phlebitis and thrombophlebitis of superficial vessels of lower extremities
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Interventions/Observational Groups

  •   About 300 patients with new diagnosis of venous thrombembolism who recieve inpatient or outpatient treatment in the hospitals of charite Berlin or Vivantes GmbH Berlin shall be included in the study. If a malignant disease is known or newly diagnosed, the patient will be observed for further six months follow-up time. Patients without malignant disease are evaluated once and do not take part in follow-up.
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Characteristics

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

Primary aim in the context of health care research is the documentation of the actual clinical practice of the treatment of these patients. By means of this registry study it will be possible for the first time to collect data on the patients’ medical history/career and medical pathways.

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Secondary Outcome

not relevant

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/05/10
  •   300
  •   Multicenter trial
  •   National
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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 malignant disease of any kind and newly diagnosed venous thromboembolism who received inpatient or outpatient treatment in the hospitals of Vivantes/Charite. The malignant disease should have been diagnosed or have required treatment during the past two years.Patients with venous thromboembolism in whom malignant disease is diagnosed for the first time, in the course of diagnostic procedures due to venous thrombembolism

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Exclusion Criteria

Patients suffering venous thromboembolism but not malignant disease will be registered only once by with reduced baseline documentation. There will be no follow up. They will not take part in follow-up-investigation.

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Addresses

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    • Vivantes Klinikum im FriedrichshainKlinik für Innere Medizin/Angiologie , Funktionsbereich Hämostaseologie
    • Mr.  Dr.  Robert  Klamroth 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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    • Vivantes Klinikum im FriedrichshainKlinik für Innere Medizin/Angiologie , Funktionsbereich Hämostaseologie
    • Mr.  Dr.  Robert  Klamroth 
    • Landsbeger Allee49
    • 10249  Berlin
    • Germany
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    • Vivantes Klinikum im FriedrichshainKlinik für Innere Medizin/Angiologie , Funktionsbereich Hämostaseologie
    • Mr.  Dr.  Robert  Klamroth 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • LEO Pharma GmbH
    • Frankfurter Str. 233 A
    • 63263  Neu-Isenburg
    • 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.