Trial document





This trial has been registered retrospectively.
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  DRKS00004818

Trial Description

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Title

Registry for health care research and quality assurance in private oncological practices

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Trial Acronym

ONCOReg

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URL of the Trial

http://www.oncoreg.de

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Brief Summary in Lay Language

The aim of ONCOReg is to gain insights on the treatment of patients with oncological or hematological diseases and to improve the quality of care in oncological practices.
These findings will enable physicians to provide the best treatment available.

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Brief Summary in Scientific Language

The aim of ONCOReg is a registry for healthcare research and quality assurance in the field of out-Patient oncological care. Focus of the registry is is the non-interventional, longitudinal and epidemiological analysis of administrative and clinical data as a tooling for quality assurance in the treatment of oncological practices.

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Organizational Data

  •   DRKS00004818
  •   2013/04/26
  •   [---]*
  •   no
  •   Approved
  •   PV4253, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1141-1812 
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Health Condition or Problem studied

  •   oncological and hematological diseases
  •   C00-D48 -  Neoplasms
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Interventions/Observational Groups

  •   Data from patients with oncological or hematological disease are recorded in a questionnaire structured by history, the course of therapy and final survey . Follow-up data will be documented according to defined intervals in a separate questionnaire.
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Characteristics

  •   Non-interventional
  •   Observational 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

The primary objective is the acquisition and representation of real-life treatment in the outpatient sector. Recorded variables are defined in the common single oncological basic data set of ADT /GEKID. Additionally, data of therapy regime and its change over time is collected. The entire therapy course of a Patient will be collected from diagnosis until death or for a five year period in adjuvant therapies each patient history including all therapies of a patient.
The following epidemiological surveys should be specified ubiquitously:
- Relative survival of cancer patients in Germany
- Penetration guideline-based therapies in oncology outpatient practice
- Definition of reference- or metadata
Furthermore, the possibility of defining reference intervals for measures (quality indicators) that could be used as the basis for quality management systems should be analyzed.

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Secondary Outcome

not relevant

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/02/20
  •   5000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- Patient with confirmed oncological / hematological diagnosis
- At least one oncological treatment
- Beginning of documented therapy must not be longer than 10 months.
- Declaration of consent

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Exclusion Criteria

none

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Addresses

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    • rgb Onkologisches Management GmbH
    • Mr.  Rainer  Goettel 
    • Paul-Lincke-Str. 14
    • 31157  Sarsted
    • Germany
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    • rgb Onkologisches Management GmbH
    • Mr.  Dr.  Markus  Kersting 
    • Hannah-Arendt-Str. 4
    • 30966  Hemmingen
    • Germany
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    • rgb Onkologisches Management GmbH
    • Mr.  Dr.  Markus  Kersting 
    • Hannah-Arendt-Str. 4
    • 30966  Hemmingen
    • Germany
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Sources of Monetary or Material Support

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    • Mundipharma GmbH
    • Mundipharma Straße 6
    • 65549  Limburg (Lahn)
    • Germany
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    • Fresenius Biotech GmbH
    • Frankfurter Ring 193 a
    • 80807  München
    • Germany
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    • medac GmbH
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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    • Onkovis
    • Grube 45
    • 82377  Penzberg
    • Germany
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    • PharmaMar S.A. Soc. Unipersonal (Grupo Zeltia)
    • Avda. de los Reyes 1 (Pol.Ind. La Mina-Norte)
    • 28770  Colmenar Viejo
    • Spain
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    • ribosepharm division
    • Lochhamer Schlag 17
    • 82166  Gräfelfing
    • Germany
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    • Sanofi-Aventis Deutschland GmbH
    • Potsdamer Straße 8
    • 10785  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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