Breast Cancer During Pregnancy (BRCAPRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT02102282
First received: March 29, 2014
Last updated: April 1, 2014
Last verified: March 2014
  Purpose

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.


Condition
Pregnancy
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Breast Cancer Diagnosed During Pregnancy

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Perinatal results [ Time Frame: Delivery ] [ Designated as safety issue: Yes ]
    Gestational age, weight, Apgar, blood tests


Secondary Outcome Measures:
  • Maternal outcome [ Time Frame: 5 year and 10 year ] [ Designated as safety issue: Yes ]
    Over all survival, disease free survival


Biospecimen Retention:   Samples With DNA

Blood and tissue samples


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subject study
Patients with breast cancer during pregnancy

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with breast cancer diagnosed during pregnancy

Criteria

Inclusion Criteria:

  • Patients with breast cancer diagnosed during pregnancy

Exclusion Criteria:

  • Patients who refuse informed consent
  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: NCT02102282

Contacts
Contact: Octavi Cordoba, PhD 34934893184 ocordoba@vhebron.net
Contact: Cristina Saura, MD 34934893105 csaura@vhebron.net

Locations
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Octavi Cordoba, PhD, MD    34934893174    ocordoba@vhebron.net   
Contact: Cristina Saura, MD    34934893105    csaura@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         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Octavi Cordoba, PhD MD Hospital Universitari Vall d'Hebron
  More Information

Publications:
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02102282     History of Changes
Other Study ID Numbers: PR(AMI)83/2012
Study First Received: March 29, 2014
Last Updated: April 1, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Pregnancy
Breast Cancer
Chemotherapy
Surgery
Obstetric managment

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

ClinicalTrials.gov processed this record on August 19, 2014