Trial document





This trial has been registered retrospectively.
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  DRKS00012995

Trial Description

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Title

German testicular cancer thrombosis register study

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Trial Acronym

TEK-Register study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Data on incidence of chemotherapy-associated thrombosis during chemotherapy of testicular cancer patients only exist from retrospective studies. This multicentre, prospective register study
includes testicular cancer patients before starting chemotherapy. Study-related interventions are an interview before starting chemotherapy and a telephone interview one year after completing chemotherapy. Invasive interventions do not take place.
Objectives are: 1. Determination of frequency of thrombosis during chemotherapy of testicular cancer patients 2. Time of onset of thrombosis.

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Brief Summary in Scientific Language

Data on incidence of chemotherapy-associated thrombosis during chemotherapy of testicular cancer patients only exist from retrospective studies. This multicentre, prospective register study
includes testicular cancer patients before starting chemotherapy. Thrombosis at baseline is detected by the initial staging CT.
Study-related interventions are an interview before starting chemotherapy and a telephone interview one year after completing chemotherapy. Invasive interventions do not take place.
Objectives are: 1. Determination of frequency of thrombosis during chemotherapy of testicular cancer patients 2. Time of onset of thrombosis.

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Organizational Data

  •   DRKS00012995
  •   2018/04/23
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  •   yes
  •   Approved
  •   837.397.14 (9636), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   C62 -  Malignant neoplasm of testis
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Interventions/Observational Groups

  •   Data on incidence of chemotherapy-associated thrombosis during chemotherapy of testicular cancer patients only exist from retrospective studies. This multicentre, prospective register study
    includes testicular cancer patients before starting chemotherapy. Thrombosis at baseline is detected by the initial staging CT.
    Study-related interventions are an interview before starting chemotherapy and a telephone interview one year after completing chemotherapy. Invasive interventions do not take place.
    Objectives are: 1. Determination of frequency of thrombosis during chemotherapy of testicular cancer patients 2. Time of onset of thrombosis.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   No
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Primary Outcome

Incidence of thromboembolic complications during and up to one year after completing chemotherapy.

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Secondary Outcome

Evaluation of potential risk factors; Localization of thrombosis; Consequences of thrombosis (e.g., cessation of chemotherapy).
Study-related interventions are an interview before starting chemotherapy and a telephone interview one year after completing chemotherapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2015/01/01
  •   450
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Chemotherapy due to testicular cancer

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Exclusion Criteria

Simultaneous or previous malignant diseases; Age <18 years; Female or intersexuality

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Addresses

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    • Bundeswehrzentralkrankenhaus KoblenzKlinik für Urologie
    • 56072  Koblenz
    • Germany
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    • Bundeswehrzentralkrankenhaus KoblenzKlinik für Urologie
    • Mr.  Dr.  Tim  Nestler 
    • Rübenacherstr. 170
    • 56072  Koblenz
    • Germany
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    • Bundeswehrzentralkrankenhaus KoblenzKlinik für Urologie
    • Mr.  Dr.  Tim  Nestler 
    • Rübenacherstr. 170
    • 56070  Koblenz
    • Germany
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Sources of Monetary or Material Support

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    • Sanitätsdienst der BundeswehrSanitätsakademie der BundeswehrAbteilung E
    • 80939  München
    • 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.