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Trial Title:
Breast Cancer in Pregnancy Register Study
NCT ID:
NCT00196833
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer in Pregnancy
Prospective and Retrospective Register
Study
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
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.
Criteria for eligibility:
Study pop:
Cohort 1: Women with histologically confirmed breast cancer during pregnancy
Cohort 2: Young women (age ≤ 40 years) with histologically confirmed breast cancer
(outside of pregnancy or recently pregnant)
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Cohort 1: Women with histologically confirmed breast cancer during pregnancy
- Cohort 2: Patients ≤ 40 years with histological confirmed breast cancer who are not
pregnant (patients who have been pregnant recently can also be collected into this
cohort)
- Informed consent for data collection (for prospective participants) and biomaterial
collection. For retrospective participants an informed consent is not required as
long as the data are anonymously captured
Exclusion Criteria:
- Cohort 1: Diagnosis of breast cancer outside the period of pregnancy
- Cohort 2: Age at diagnosis of breast cancer > 40 years
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
German Breast Group
Address:
City:
Neu-Isenburg
Zip:
63263
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sibylle Loibl, Prof. Dr.
Phone:
+49 6102 7840
Phone ext:
426
Email:
Sibylle.Loibl@gbg.de
Investigator:
Last name:
Sibylle Loibl, Prof. Dr.
Email:
Principal Investigator
Start date:
April 2003
Completion date:
April 2026
Lead sponsor:
Agency:
German Breast Group
Agency class:
Other
Collaborator:
Agency:
Goethe University
Agency class:
Other
Source:
German Breast Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00196833
http://www.germanbreastgroup.de
