Trial Description

DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
Breast cancer surveillance in women with radiation of Hodgkin´s disease during
childhood and adolescence including breast area
Trial Acronym
[---]*
URL of the trial
http://familiaerer-brust-und-eierstockkrebs.uk-koeln.de/forschung/klinischesstudienzentrum/hodgkin
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.
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.
Organizational Data
DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
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DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 12-325 , Ethik-Kommission der Medizinischen Fakultät
der Universität zu Köln
Secondary IDs
Health condition or Problem studied
ICD10: C50 - Malignant neoplasm of breast
ICD10: C81 - Hodgkin lymphoma
Interventions/Observational Groups
Arm 1: 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
Characteristics
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Single arm study
Blinding: [---]*
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Screening
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DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Single arm study
Blinding: [---]*
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Screening
Assignment: Single (group)
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A
Primary Outcome
Prospective incidence of secondary breast cancers in women after radiation of
Hodgkin´s disease including breast area in childhood and adolescence
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
Countries of recruitment
DE Germany
Locations of Recruitment
University Medical Center Zentrum Familiärer Brust- und Eierstockkrebs, Köln
University Medical Center Charite Campus Mitte, Institut für Radiologie, Zentrum
Familiärer Brust- und Eierstockkrebs, Berlin
Medical Center Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe,
Zentrum Familiärer Brust- und Eierstockkrebs, Dresden
University Medical Center Zentrum Familiärer Brust- und Eierstockkrebs,
Düsseldorf
University Medical Center Zentrum Frauenheilkunde Gynäkologie und
Geburtshilfe, Zentrum Familiärer Brust- und Eierstockkrebs, Göttingen
University Medical Center Medizinische Hochschule Hannover, Institut für
diagnostische und interventionelle Radiologie, Zentrum Familiärer Brust- und
Eierstockkrebs, Hannover
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DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
University Medical Center Brustzentrum Universitäts-Frauenklinik, Zentrum
Familiärer Brust- und Eierstockkrebs, Heidelberg
University Medical Center Frauenklinik, Zentrum Familiärer Brust- und
Eierstockkrebs, Kiel
University Medical Center Zentrum Familiärer Brust- und Eierstockkrebs, Köln
University Medical Center Brustzentrumk Zentrum familiärer Brust- und
Eierstockkrebs, Leipzig
University Medical Center Zentrum München-Großhadern, Frauenklinik und
Poliklinik, Zentrum Familiärer Brust- und Eierstockkrebs, München
University Medical Center Zentrum TU München, Zentrum Familiärer Brust- und
Eierstockkrebs, München
University Medical Center Zentrum Familiärer Brust- und Eierstockkrebs, Münster
University Medical Center Frauenklinik, Zentrum Familiärer Brust- und
Eierstockkrebs, Regensburg
University Medical Center Zentrum Familiärer Brust- und Eierstockkrebs, Tübingen
University Medical Center Klinik für Frauenheilkunde und Geburtshilfe, Zentrum
Familiärer Brust- und Eierstockkrebs, Ulm
University Medical Center Zentrum Familiärer Brust- und Eierstockkrebs,
Würzburg
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2013/11/25
Target Sample Size: 500
Monocenter/Multicenter trial: Multicenter trial
National/International: National
Inclusion Criteria
Gender: Female
Minimum Age: 25 Years
Maximum Age: 50 Years
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
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
Page 4 of 6
DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
Addresses
Primary Sponsor
Uniklinik Köln
Kerpener Str. 62
50931 Köln
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: http://www.uk-koeln.de
Contact for Scientific Queries
Zentrum Familiärer Brust- und Eierstockkrebs
Ms. Prof. Dr. med. Rita Schmutzler
Kerpener Str. 34
50931 Köln
Germany
Telephone: +49 221 478 86509
Fax: +49 221 478 86510
E-mail: rita.schmutzler at uk-koeln.de
URL: http://familiaerer-brust-und-eierstockkrebs.uk-koeln.de/
Contact for Public Queries
Zentrum Familiärer Brust- und Eierstockkrebs
Ms. PD Dr. med. Kerstin Rhiem
Kerpener Str. 34
50931 Köln
Germany
Telephone: +49 221 478 86688
Fax: +49 221 478 86510
E-mail: kerstin.rhiem at uk-koeln.de
URL: [---]*
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body
(German Research Foundation (DFG), Federal Ministry of Education and
Research (BMBF), etc.)
Krankenkassen nach Einzelfallentscheidung
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DRKS-ID: DRKS00004910
Date of Registration in DRKS: 2014/05/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
Public funding institutions financed by tax money/Government funding body
(German Research Foundation (DFG), Federal Ministry of Education and
Research (BMBF), etc.)
Krankenkassen nach Einzelfallentscheidung
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Public funding institutions financed by tax money/Government funding body
(German Research Foundation (DFG), Federal Ministry of Education and
Research (BMBF), etc.)
AOK Rheinland-Hamburg
Kasernenstr. 61
40213 Düsseldorf
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
Paper Veröffentlichung Deutsches Ärzteblatt
* This entry means the parameter is not applicable or has not been set.
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