Trial document





This trial has been registered retrospectively.
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  DRKS00004910

Trial Description

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Title

Breast cancer surveillance in women with radiation of Hodgkin´s disease during childhood and adolescence including breast area

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Trial Acronym

[---]*

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URL of the Trial

http://familiaerer-brust-und-eierstockkrebs.uk-koeln.de/forschung/klinisches-studienzentrum/hodgkin

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Brief Summary in Lay Language

Patients after radiation of Hodgkin´s disease show an increased rate of secondary cancers. Women exhibit a higher frequency of secondary breast carcinomas after radiation including the breast area. National and international experts demand a structured breast cancer surveillance program for women after radiation of the breast area during childhood and adolescence. Women after radiation and women with hereditary risk for breast cancer share characteristic features (early age of onset, elevated risk for breast cancer). The German Consortium for Hereditary Breast and Ovarian cancer established a multimodal breast cancer surveillance program. This program will be offered to women after radiation of HD in childhood and adolescence.

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Brief Summary in Scientific Language

Patients after radiation of Hodgkin´s disease show an increased rate of secondary cancers. Women exhibit a higher frequency of secondary breast carcinomas after radiation including the breast area. National and international experts demand a structured breast cancer surveillance program for women after radiation of the breast area during childhood and adolescence. Women after radiation and women with hereditary risk for breast cancer share characteristic features (early age of onset, elevated risk for breast cancer). The German Consortium for Hereditary Breast and Ovarian cancer established a multimodal breast cancer surveillance program. This program will be offered to women after radiation of HD in childhood and adolescence.

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Organizational Data

  •   DRKS00004910
  •   2014/05/05
  •   [---]*
  •   yes
  •   Approved
  •   12-325, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   C50 -  Malignant neoplasm of breast
  •   C81 -  Hodgkin lymphoma
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Interventions/Observational Groups

  •   Women after radiation of hodgkin´s disease in childhood and adolescence including breast area:
    - Instruction for self-examination of the breast
    - Every 6 months medical examination of the breast and mammasonography
    - Every 12 months magnetic resonance imaging of the breast (age 25 years or older)
    - Mammography every 1-2 years according to individual risk-benefit evaluation or in case of unclear or suspect findings additionally from 40 years of age
    - Early detection of breast cancer for the female general public (i.e. mammography screening) from 50 years of age
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prospective incidence of secondary breast cancers in women after radiation of Hodgkin´s disease including breast area in childhood and adolescence

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Secondary Outcome

- analyses of sensitivity, specificity, positive predictive value and negative predictive value of the diagnostic procedures (breast sonography, mammography, MRI of the breasts)
- influence of early breast cancer detection on mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2013/11/25
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   25   Years
  •   50   Years
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Additional Inclusion Criteria

≥ 25 years, female, radiation of hodgkin´s disease including breast area in childhood and adolescence, no contraindication against one of the diagnostic procedures, informed consent

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Exclusion Criteria

≥ 50 years of age, pregnancy, lactation, contraindication for MRI of the breast (e.g. cardiac pacemaker, patient at risk for nephrogenic systemic fibrosis

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Addresses

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    • Uniklinik Köln
    • Kerpener Str. 62
    • 50931  Köln
    • Germany
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    • Zentrum Familiärer Brust- und Eierstockkrebs
    • Ms.  Prof. Dr. med.   Rita  Schmutzler 
    • Kerpener Str. 34
    • 50931  Köln
    • Germany
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    • Zentrum Familiärer Brust- und Eierstockkrebs
    • Ms.  PD Dr. med.   Kerstin  Rhiem 
    • Kerpener Str. 34
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Krankenkassen nach Einzelfallentscheidung
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    •   [---]*
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    • AOK Rheinland-Hamburg
    • Kasernenstr. 61
    • 40213  Düsseldorf
    • Germany
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    •   [---]*
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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.