Breast Cancer in Pregnancy Register Study (BCP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by German Breast Group
Sponsor:
Collaborator:
University Hospital, Frankfurt
Information provided by (Responsible Party):
German Breast Group
ClinicalTrials.gov Identifier:
NCT00196833
First received: September 12, 2005
Last updated: February 9, 2016
Last verified: February 2016
  Purpose

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
Breast Cancer

Study Type: Observational
Official Title: Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy

Resource links provided by NLM:


Further study details as provided by German Breast Group:

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

Estimated Enrollment: 500
Study Start Date: April 2003
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196833

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

Locations
Germany
German Breast Group Recruiting
Neu Isenburg, Hessen, Germany, 63263
Contact: Sibylle Loibl, PD.MD    +49 6102 7840 ext 426    Sibylle.Loibl@GermanBreastGroup.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 
Study First Received: September 12, 2005
Last Updated: February 9, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 25, 2016