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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
December 22, 2011
January 31, 2012
September 4, 2017
December 2010
December 2019   (Final data collection date for primary outcome measure)
molecular alteration in breast cancer [ Time Frame: average of 4 weeks after diagnosis ]
gene expression level
Same as current
Complete list of historical versions of study NCT01521676 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Predictive Clinical and Biological Parameters in Breast Cancer
Research of Predictive Clinical and Biological Parameters in Breast Cancer

Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Breast Cancer
Genetic: molecular alteration
research of molecular alteration
Experimental: breast cancer
blood and tumor sample
Intervention: Genetic: molecular alteration
Gonçalves A, Bertucci F, Guille A, Garnier S, Adelaide J, Carbuccia N, Cabaud O, Finetti P, Brunelle S, Piana G, Tomassin-Piana J, Paciencia M, Lambaudie E, Popovici C, Sabatier R, Tarpin C, Provansal M, Extra JM, Eisinger F, Sobol H, Viens P, Lopez M, Ginestier C, Charafe-Jauffret E, Chaffanet M, Birnbaum D. Targeted NGS, array-CGH, and patient-derived tumor xenografts for precision medicine in advanced breast cancer: a single-center prospective study. Oncotarget. 2016 Nov 29;7(48):79428-79441. doi: 10.18632/oncotarget.12714.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2029
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • breast cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

  • emergency
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD PhD 33491223778 drci.up@ipc.unicancer.fr
France
 
 
NCT01521676
BC-BIO/IPC 2009-005
No
Not Provided
Not Provided
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Not Provided
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
Institut Paoli-Calmettes
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP