- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102282
Breast Cancer During Pregnancy (BRCAPRE)
April 1, 2014 updated by: Hospital Universitari Vall d'Hebron Research Institute
Observational Study of Breast Cancer Diagnosed During Pregnancy
Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team.
Clinical decisions are made after a patient physician discussion.
Blood and tissue samples are collected.
Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Vall d'Hebron
-
Contact:
- Cristina Saura, MD
- Phone Number: 34934893105
- Email: csaura@vhebron.net
-
Contact:
- Octavi Cordoba, PhD, MD
- Phone Number: 34934893174
- Email: ocordoba@vhebron.net
-
Principal Investigator:
- Octavi Cordoba, PhD, MD
-
Sub-Investigator:
- Cristina Saura, MD
-
Sub-Investigator:
- Elisa Llurba, PhD, MD
-
Sub-Investigator:
- Isabel T Rubio, Ph D, MD
-
Sub-Investigator:
- Javier Cortes, PhD, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients with breast cancer diagnosed during pregnancy
Description
Inclusion Criteria:
- Patients with breast cancer diagnosed during pregnancy
Exclusion Criteria:
- Patients who refuse informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Subject study
Patients with breast cancer during pregnancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perinatal results
Time Frame: Delivery
|
Gestational age, weight, Apgar, blood tests
|
Delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal outcome
Time Frame: 5 year and 10 year
|
Over all survival, disease free survival
|
5 year and 10 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Octavi Cordoba, PhD MD, Hospital Vall d'Hebron
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cordoba O, Llurba E, Saura C, Rubio I, Ferrer Q, Cortes J, Xercavins J. Multidisciplinary approach to breast cancer diagnosed during pregnancy: maternal and neonatal outcomes. Breast. 2013 Aug;22(4):515-9. doi: 10.1016/j.breast.2012.10.005. Epub 2012 Oct 30.
- Cordoba O, Llurba E, Cortes J, Sabadell MD, Lirola JL, Ferrer Q, Xercavins J. Complete pathological remission in a patient with hormone-receptor positive and c-erbB-2 expression-negative breast cancer treated with FAC chemotherapy during pregnancy. Tumori. 2010 Jul-Aug;96(4):629-32. doi: 10.1177/030089161009600420.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
March 29, 2014
First Submitted That Met QC Criteria
April 1, 2014
First Posted (Estimate)
April 2, 2014
Study Record Updates
Last Update Posted (Estimate)
April 2, 2014
Last Update Submitted That Met QC Criteria
April 1, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(AMI)83/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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