Trial document




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  DRKS00009989

Trial Description

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Title

Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed Breast or Ovarian Cancer
The BRandO Biology and Outcome (BiO)-Project

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Trial Acronym

BRandO BiO

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

All patients with newly diagnosed primary breast or ovarian cancer of all BRandOBiO centers in Germany are intended to be registered within the BRandO BiO Registry. In all patients analyses of tumor tissue will be performed according to TNM (6. edition) classification. Analyses include morphology of tumor cells, immunophenotyping and molecular genetic studies. Biobanking of patient material is organized in reference laboratories. For all patients participating in this registry study the documentation of a minimal data set is required. Data documented will be recorded according to the requirements for certified breast and gynecologic oncology centers. BRandO biobank and clinical database are primarily academic and research-driven. This does not exclude the possibility of common projects with biotech and pharmaceutical companies if agreed by the executive committee. In addition, samples collected under the umbrella of the CCCU biobank and laboratories Section Gynecologic Oncology, Frauenklinik are handled according to the respective standing orders.
The biomaterials of each contributing party can only be used for corresponding research projects if agreed on by the contributing party in written form. This does not only concern research projects being proposed from within the BRandO study group, but also possible research projects from other biotech or pharmaceutical companies.

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Organizational Data

  •   DRKS00009989
  •   2016/02/04
  •   [---]*
  •   yes
  •   Approved
  •   285/15, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   BRandO BiO_12_06_2015 
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   1. register all patients with newly diagnosed breast or ovarian cancer in all BRandO-BiO participating centers
    2. assess and verify tumor classification and other data according to the requirements for certified breast and gynecologic oncology centers
    3. assess clinical characteristics and outcome data (response, event-free survival [EFS], progression-free survival, overall survival [OS])
    4. assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
    5. store liquid biopsy samples from all patients (blood and plasma samples)
    6. establish a tumorbank with paraffin embedded samples
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Objectives:
- Incidence of different molecular aberrations
- To document treatment decisions (intensive, non-intensive, investigational)
- Progression-free survival (PFS)
- Overall survival (OS)

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2016/01/18
  •   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

Patients with primary newly diagnosed of breast or ovarian cancer
Age ≥ 18 years. There is no upper age limit.
signed informed consent

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Exclusion Criteria

Severe neurological or psychiatric disorder interfering with ability to give an informed consent
No consent for registration, storage and processing of the individual disease characteristics and course

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum UlmKlinik für Frauenheilkunde und Geburtshilfe
    • Mr.  Prof. Dr.   Jens  Huober 
    • Prittwitzstr, 43
    • 89075  Ulm
    • Germany
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    • Universitätsklinikum UlmKlinik für Frauenheilkunde und Geburtshilfe
    • Mr.  Prof. Dr.  Jens  Huober 
    • Prittwitzstr. 43
    • 89075  Ulm
    • Germany
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    • Universitätsklinikum Ulm, Klinik für Frauenheilkunde und Geburtshilfe
    • Mr.  Prof. Dr.  Jens  Huober 
    • Prittwiztstr. 43
    • 89075  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Ulm
    • Mr.  Prof. Dr.   Jens  Huober 
    • Prittwitzstr. 43
    • 89075  Ulm
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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