NCT02102282

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

10.2 years

First QC Date

March 29, 2014

Last Update Submit

April 1, 2014

Conditions

PregnancyBreast Cancer

Keywords

PregnancyBreast CancerChemotherapySurgeryObstetric managment

Outcome Measures

Primary Outcomes (1)

  • Perinatal results

    Gestational age, weight, Apgar, blood tests

    Delivery

Secondary Outcomes (1)

  • Maternal outcome

    5 year and 10 year

Study Arms (1)

Subject study

Patients with breast cancer during pregnancy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer diagnosed during pregnancy

You may qualify if:

  • Patients with breast cancer diagnosed during pregnancy

You may not qualify if:

  • Patients who refuse informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23116970RESULT

  • 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.

    PMID: 20968147RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Octavi Cordoba, PhD MD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Octavi Cordoba, PhD

CONTACT

34934893184ocordoba@vhebron.net

Cristina Saura, MD

CONTACT

34934893105csaura@vhebron.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2014

First Posted

April 2, 2014

Study Start

October 1, 2012

Primary Completion

December 1, 2022

Last Updated

April 2, 2014

Record last verified: 2014-03

Locations

ES(2)