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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Institut Paoli-Calmettes
Information provided by (Responsible Party):
Institut Paoli-Calmettes Identifier:
First received: December 22, 2011
Last updated: November 30, 2015
Last verified: November 2015

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: 750
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


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

Inclusion Criteria:

  • breast cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

  • emergency
  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 identifier: NCT01521676

Contact: Dominique GENRE, MD 33491223778
Contact: Jihane PAKRADOUNI, PharmD PhD 33491223778

Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Contact: Carole TARPIN, MD    33491223778   
Principal Investigator: Carole TARPIN, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
  More Information

Additional Information:
Responsible Party: Institut Paoli-Calmettes Identifier: NCT01521676     History of Changes
Other Study ID Numbers: BC-BIO/IPC 2009-005 
Study First Received: December 22, 2011
Last Updated: November 30, 2015
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
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on May 26, 2016