Predictive Clinical and Biological Parameters in Breast Cancer (BC-BIO)
This study is currently recruiting participants.
Verified March 2013 by Institut Paoli-Calmettes
Sponsor:
Institut Paoli-Calmettes
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01521676
First received: December 22, 2011
Last updated: March 19, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 22, 2011 | ||||||||
| Last Updated Date | March 19, 2013 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
molecular alteration in breast cancer [ Time Frame: average of 4 weeks after diagnosis ] [ Designated as safety issue: No ] gene expression level |
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| 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 |
relation between molecular alteration and clinical and histological characteristics [ Time Frame: up to 3 years ] [ Designated as safety issue: No ] hazard ratio between molecular alteration and clinical and histological characteristics |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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 |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE | Genetic: molecular alteration
research of molecular alteration
Other Name: molecular alteration |
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| Study Arm (s) | Experimental: breast cancer
blood and tumor sample
Intervention: Genetic: molecular alteration |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01521676 | ||||||||
| Other Study ID Numbers ICMJE | BC-BIO/IPC 2009-005 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Institut Paoli-Calmettes | ||||||||
| Study Sponsor ICMJE | Institut Paoli-Calmettes | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Institut Paoli-Calmettes | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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