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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
molecular alteration
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • breast cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

  • emergency

Sites / Locations

  • Institut Paoli CalmettesRecruiting
  • Hôpital Sainte-MusseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

breast cancer

Arm Description

blood and tumor sample

Outcomes

Primary Outcome Measures

molecular alteration in breast cancer
gene expression level

Secondary Outcome Measures

relation between molecular alteration and clinical and histological characteristics
hazard ratio between molecular alteration and clinical and histological characteristics

Full Information

First Posted
December 22, 2011
Last Updated
September 1, 2017
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT01521676
Brief Title
Predictive Clinical and Biological Parameters in Breast Cancer
Acronym
BC-BIO
Official Title
Research of Predictive Clinical and Biological Parameters in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Recruiting
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
breast cancer
Arm Type
Experimental
Arm Description
blood and tumor sample
Intervention Type
Genetic
Intervention Name(s)
molecular alteration
Intervention Description
research of molecular alteration
Primary Outcome Measure Information:
Title
molecular alteration in breast cancer
Description
gene expression level
Time Frame
average of 4 weeks after diagnosis
Secondary Outcome Measure Information:
Title
relation between molecular alteration and clinical and histological characteristics
Description
hazard ratio between molecular alteration and clinical and histological characteristics
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: breast cancer age > 18 signed informed consent Exclusion Criteria: emergency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
33491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jihane PAKRADOUNI, PharmD PhD
Phone
33491223778
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole TARPIN, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole TARPIN, MD
Phone
33491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Carole TARPIN, MD
Facility Name
Hôpital Sainte-Musse
City
Toulon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric VIRET, MD
Email
frederic.viret@ch-toulon.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
27765906
Citation
Goncalves 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.
Results Reference
derived
Links:
URL
http://www.institutpaolicalmettes.fr
Description
official web site of the sponsor

Learn more about this trial

Predictive Clinical and Biological Parameters in Breast Cancer

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