Predictive Clinical and Biological Parameters in Breast Cancer (BC-BIO)

This study is currently recruiting participants.
Verified December 2013 by Institut Paoli-Calmettes
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01521676
First received: December 22, 2011
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation


Condition Intervention
Breast Cancer
Genetic: molecular alteration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Research of Predictive Clinical and Biological Parameters in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • molecular alteration in breast cancer [ Time Frame: average of 4 weeks after diagnosis ] [ Designated as safety issue: No ]
    gene expression level


Secondary Outcome Measures:
  • relation between molecular alteration and clinical and histological characteristics [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    hazard ratio between molecular alteration and clinical and histological characteristics


Estimated Enrollment: 500
Study Start Date: December 2010
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: breast cancer
blood and tumor sample
Genetic: molecular alteration
research of molecular alteration
Other Name: molecular alteration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

  • emergency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521676

Contacts
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Contact: Agnès BOYER CHAMMARD, MD 33491223778 drci.up@ipc.unicancer.fr

Locations
France
Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Contact: Carole TARPIN, MD    33491223778    drci.up@ipc.unicancer.fr   
Principal Investigator: Carole TARPIN, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01521676     History of Changes
Other Study ID Numbers: BC-BIO/IPC 2009-005
Study First Received: December 22, 2011
Last Updated: December 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
breast cancer

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

ClinicalTrials.gov processed this record on April 16, 2014