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Breast Cancer in Pregnancy Register Study (BCP)

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ClinicalTrials.gov Identifier: NCT00196833
Recruitment Status : Recruiting
First Posted : September 20, 2005
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Women who were diagnosed with breast cancer during their pregnancy may be registered in this trial.

Data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of pregnancy as well as the breast cancer therapy applied (treatment, response to chemotherapy, type of surgery), diagnostic procedures applied (palpation, US, mammogram) and the outcome of mother and child after 5 years of therapy.


Condition or disease
Breast Cancer

Detailed Description:
Breast cancer is the most common cancer malignancy in women of childbearing age after the age of 25 years. Since the incidence of breast cancer under the age of 40 is increasing, and women tend to delay pregnancy into later reproductive years, the coincidence of pregnancy and breast cancer is increasing. About 1 in 1,000 pregnancies is complicated by breast cancer. Nevertheless, little is known about the right therapy for the mother and the unborn child. We are therefore carrying out a trial, collecting prospective and retrospective data about pregnant women, with histological confirmed breast cancer. Data on the biology of the tumour and placenta tissues is also collected. The anonymous data is collected in a database.

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Official Title: Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy
Study Start Date : April 2003
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples With DNA
Tumour and placenta specimens are collected

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with histologically confirmed breast cancer during pregnancy.
Criteria

Inclusion Criteria:

  • Women with histologically confirmed breast cancer during pregnancy.
  • Informed consent for data and specimen collection.

Exclusion Criteria:

  • Diagnosis of breast cancer outside the period of pregnancy.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196833


Contacts
Contact: Sibylle Loibl, PD.MD +49 6102-7480- ext 426 Sibylle.Loibl@gbg.de

Locations
Germany
German Breast Group Recruiting
Neu Isenburg, Hessen, Germany, 63263
Contact: Sibylle Loibl, PD.MD    +49 6102 7840 ext 426    Sibylle.Loibl@gbg.de   
Principal Investigator: Sibylle Loibl, MD         
Sponsors and Collaborators
German Breast Group
University Hospital, Frankfurt
Investigators
Principal Investigator: Sibylle Loibl, PD.MD German Breast Group
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Breast Group
ClinicalTrials.gov Identifier: NCT00196833     History of Changes
Other Study ID Numbers: GBG 29
BIG 2-03 ( Other Identifier: BIG )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017

Keywords provided by German Breast Group:
Breast Cancer in Pregnancy
Prospective and Retrospective Register
Study

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases