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

This study is currently recruiting participants.
Verified September 2017 by Institut Paoli-Calmettes
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521676
First Posted: January 31, 2012
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Paoli-Calmettes
  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: None (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 ]
    gene expression level


Secondary Outcome Measures:
  • relation between molecular alteration and clinical and histological characteristics [ Time Frame: up to 3 years ]
    hazard ratio between molecular alteration and clinical and histological characteristics


Estimated Enrollment: 750
Study Start Date: December 2010
Estimated Study Completion Date: December 2029
Estimated Primary Completion Date: December 2019 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

  • emergency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521676


Contacts
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD PhD 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         
Hôpital Sainte-Musse Recruiting
Toulon, France
Contact: Frédéric VIRET, MD       frederic.viret@ch-toulon.fr   
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01521676     History of Changes
Other Study ID Numbers: BC-BIO/IPC 2009-005
First Submitted: December 22, 2011
First Posted: January 31, 2012
Last Update Posted: September 4, 2017
Last Verified: September 2017

Keywords provided by Institut Paoli-Calmettes:
breast cancer

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