Ignite Creation Date:
2024-05-06 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03495609
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2018-01-23
Brief Title:
Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
The Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
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:
Specific aim To establish the proof of principle that treatment of high breast cancer risk women with recombinant human chorionic gonadotropin r-hCG will change their breast epitheliums high risk genomic profile to one similar to that identified in women with a history of early full first term pregnancy
Detailed Description:
This study is based on the investigators preclinical data that have demonstrated that r-hCG exerts a mammary cancer preventive effect that is mediated by the induction of gland differentiation which results in permanent changes in the genomic signature of this organ This exploratory study will evaluate the genomic profile of breast epithelial cells obtained from random periareolar fine needle aspiration RPFNA specimens performed in high risk women treated for 90 days an extra 4 weeks in a subgroup with r-hCG This knowledge will serve as the basis for establishing a novel genomic biomarker that will serve as a surrogate endpoint in future preventive clinical trials
The objective of the proposed study is to characterize the genomic profile of breast epithelial cells obtained from 35 asymptomatic high breast cancer risk nulliparous premenopausal women carriers of BRCA1 and BRCA2 deleterious mutations Gene expression measurements and benign breast tissue specimens will be obtained at baseline time 0 after treatment with r-hCG at 90 days time 1 at 270 days from baseline time 2 and in a subgroup at 60 weeks - 4 weeks
The primary objective of the study is to compare the gene expression profiles of these women across the three or four time points and identify differentially expressed genes The investigator is interested in comparing the expression profiles between all pairs of time points as well as across time The comparison of profiles before and after treatment with r-hCG both at 90 and 270 days are of particular interest The women will receive 3xweek injections of 250 microgram r-hCG for a total of 12 weeks an extra 4 weeks in a subgroup Core Needle Biopsies specimens will be primarily utilized for analysis of genomic expression by cDNA microarray In addition a series of surrogate intermediate markers such as cytomorphologic evaluation and cell proliferation index will be analyzed
The objective of the proposed study is to characterize the genomic profile of breast epithelial cells obtained from 35 asymptomatic high breast cancer risk nulliparous premenopausal women carriers of BRCA1 and BRCA2 deleterious mutations Gene expression measurements and benign breast tissue specimens will be obtained at baseline time 0 after treatment with r-hCG at 90 days time 1 at 270 days from baseline time 2 and in a subgroup at 60 weeks - 4 weeks
The primary objective of the study is to compare the gene expression profiles of these women across the three or four time points and identify differentially expressed genes The investigator is interested in comparing the expression profiles between all pairs of time points as well as across time The comparison of profiles before and after treatment with r-hCG both at 90 and 270 days are of particular interest The women will receive 3xweek injections of 250 microgram r-hCG for a total of 12 weeks an extra 4 weeks in a subgroup Core Needle Biopsies specimens will be primarily utilized for analysis of genomic expression by cDNA microarray In addition a series of surrogate intermediate markers such as cytomorphologic evaluation and cell proliferation index will be analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None