Breast Cancer in Pregnancy (BCP)
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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 |
Tumour and placenta specimens are collected
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women with histologically confirmed breast cancer during pregnancy.
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| Contact: Sibylle Loibl, PD.MD | +49 6102-7480- ext 426 | Sibylle.Loibl@GermanBreastGroup.de |
| 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 | |
| Principal Investigator: | Sibylle Loibl, PD.MD | German Breast Group |
More Information
Additional Information:
No publications provided by German Breast Group
Additional 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: | May 24, 2012 |
| 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 May 19, 2013