Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082979
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2004-05-14
Brief Title:
Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA12 or p53 Gene Mutations
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
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:
RATIONALE Diagnostic procedures such as breast duct endoscopy may improve the ability to detect breast cancer earlier and plan more effective treatment
PURPOSE This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia abnormal cells in the breast ducts of women with a genetic risk for breast cancer
PURPOSE This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia abnormal cells in the breast ducts of women with a genetic risk for breast cancer
Detailed Description:
OBJECTIVES
Primary
Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1 BRCA2 or p53 gene mutations who have cellular atypia
Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy
Secondary
Determine patient acceptance of duct endoscopy
Perform immunohistochemical analysis including estrogen receptor progesterone receptor HER2-neu receptor epidermal growth factor receptor p53 and proliferation marker expression for markers potentially associated with breast cancer in these patients
Determine potential molecular markers of malignancy by gene methylation gene expression and proteomics in these patients
OUTLINE Patients undergo nipple aspiration to identify productive ducts and collect fluid for tumor marker assessment followed by ductal lavage over 15 minutes Patients undergo duct endoscopy over approximately 30 minutes under local anesthesia If no abnormality is found duct endoscopy is repeated in 6 months If the repeat duct endoscopy is normal patients continue to undergo nipple aspiration or ductal lavage as specified in protocols RMNHS-2242 and RMNHS-2269 If an abnormality is found during either the initial or repeat duct endoscopy patients may undergo further assessment comprising imaging or biopsy andor appropriate surgical intervention
Fluid is analyzed for tumor markers by immunohistochemistry Candidate genes are analyzed by gene methylation studies gene expression arrays and proteomic analysis
Patients are followed for at least 5 years
PROJECTED ACCRUAL A total of 45-60 patients will be accrued for this study within 2 years
Primary
Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1 BRCA2 or p53 gene mutations who have cellular atypia
Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy
Secondary
Determine patient acceptance of duct endoscopy
Perform immunohistochemical analysis including estrogen receptor progesterone receptor HER2-neu receptor epidermal growth factor receptor p53 and proliferation marker expression for markers potentially associated with breast cancer in these patients
Determine potential molecular markers of malignancy by gene methylation gene expression and proteomics in these patients
OUTLINE Patients undergo nipple aspiration to identify productive ducts and collect fluid for tumor marker assessment followed by ductal lavage over 15 minutes Patients undergo duct endoscopy over approximately 30 minutes under local anesthesia If no abnormality is found duct endoscopy is repeated in 6 months If the repeat duct endoscopy is normal patients continue to undergo nipple aspiration or ductal lavage as specified in protocols RMNHS-2242 and RMNHS-2269 If an abnormality is found during either the initial or repeat duct endoscopy patients may undergo further assessment comprising imaging or biopsy andor appropriate surgical intervention
Fluid is analyzed for tumor markers by immunohistochemistry Candidate genes are analyzed by gene methylation studies gene expression arrays and proteomic analysis
Patients are followed for at least 5 years
PROJECTED ACCRUAL A total of 45-60 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20351 | None | None | None |
| RMNHS-2282 | None | None | None |