Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01434420
Status:
UNKNOWN
Last Update Posted:
2014-12-31
First Post:
2011-09-13
Brief Title:
Triple Negative Breast Cancer Study of Molecular and Genetic Factors
Sponsor:
Institut Paoli-Calmettes
Organization:
Institut Paoli-Calmettes
Study Overview
Official Title:
Triple Negative Breast Cancer Study of Molecular and Genetic Factors
Status:
UNKNOWN
Status Verified Date:
2014-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer triples negatives TN 15 of the cases are characterized by a high histoprognostic grade a strong proliferation a strong metastatic power and a worse prognosis than the other forms of breast cancer It is however a heterogenous group for histological and molecular level but also for evolution Most of the TN is part of the basal breast cancer subcategory Until now the medical treatment is based on chemotherapy
Breast cancers by constitutional mutation of BRCA1 BRCA2 5 of breast cancers are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors They would be much more frequent in the TN group However at this day no prospective study was led to estimate this incidence or to study the intervention of other genes of predisposition as well to analyse the links between this phenotype and their consequences at the germinal or somatic level in terms of associated molecular changes and prognosis
The purpose of this study is on a prospective study to lead a joined analysis at the germinal level in search of mutations of the main genes of breast cancer predisposition BRCA12 PALB2 PTEN PALB2 and at the tumour level tissue micro-array and transcriptome by correlating these results to the main clinical parameters
The 5 years relapse-free survival will also be estimated
Breast cancers by constitutional mutation of BRCA1 BRCA2 5 of breast cancers are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors They would be much more frequent in the TN group However at this day no prospective study was led to estimate this incidence or to study the intervention of other genes of predisposition as well to analyse the links between this phenotype and their consequences at the germinal or somatic level in terms of associated molecular changes and prognosis
The purpose of this study is on a prospective study to lead a joined analysis at the germinal level in search of mutations of the main genes of breast cancer predisposition BRCA12 PALB2 PTEN PALB2 and at the tumour level tissue micro-array and transcriptome by correlating these results to the main clinical parameters
The 5 years relapse-free survival will also be estimated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None