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

September 1, 2017 updated by: Institut Paoli-Calmettes

Research of Predictive Clinical and Biological Parameters in Breast Cancer

Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
        • Principal Investigator:
          • Carole TARPIN, MD
      • Toulon, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • breast cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

  • emergency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: breast cancer
blood and tumor sample
Genetic: molecular alteration
research of molecular alteration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
molecular alteration in breast cancer
Time Frame: average of 4 weeks after diagnosis
gene expression level
average of 4 weeks after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Carole TARPIN, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-BIO/IPC 2009-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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