BC-BIO: Predictive Clinical and Biological Parameters in Breast Cancer

• Sponsor: Institut Paoli-Calmettes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01521676
• Collaborator: (none)
• Enrollment: 750
• Locations: 2
• Arm: 1
• Duration (Months): 228
• Patients Per Site: 375
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Genetic: molecular alteration	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 750 participants
• Allocation: N/A
• 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
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. molecular alteration in breast cancer [average of 4 weeks after diagnosis]

   gene expression level

Secondary Outcome Measures

1. relation between molecular alteration and clinical and histological characteristics [up to 3 years]

   hazard ratio between molecular alteration and clinical and histological characteristics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• breast cancer

• age > 18

• signed informed consent

Exclusion Criteria:

• emergency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Paoli Calmettes	Marseille		France	13009
2	Hôpital Sainte-Musse	Toulon		France

Sponsors and Collaborators

• Institut Paoli-Calmettes

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• official web site of the sponsor

Publications

None provided.

• Responsible Party: Institut Paoli-Calmettes
• ClinicalTrials.gov Identifier: NCT01521676
• Other Study ID Numbers: BC-BIO/IPC 2009-005
• First Posted: Jan 31, 2012
• Last Update Posted: Sep 5, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by Institut Paoli-Calmettes: breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 5, 2017