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

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ClinicalTrials.gov Identifier: NCT01521676
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Tracking Information
First Submitted Date  ICMJE December 22, 2011
First Posted Date  ICMJE January 31, 2012
Last Update Posted Date September 5, 2017
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
molecular alteration in breast cancer [ Time Frame: average of 4 weeks after diagnosis ]
gene expression level
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01521676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Predictive Clinical and Biological Parameters in Breast Cancer
Official Title  ICMJE Research of Predictive Clinical and Biological Parameters in Breast Cancer
Brief Summary

Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Breast Cancer
Intervention  ICMJE Genetic: molecular alteration
research of molecular alteration
Study Arms  ICMJE Experimental: breast cancer
blood and tumor sample
Intervention: Genetic: molecular alteration
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
750
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2012)
500
Estimated Study Completion Date  ICMJE December 2029
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • breast cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

  • emergency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD PhD 33491223778 drci.up@ipc.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01521676
Other Study ID Numbers  ICMJE BC-BIO/IPC 2009-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date September 2017

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