Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00083018
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2004-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
Evaluation Of The Role Of Nipple Aspiration, Ductal Lavage And Duct Endoscopy At The Time Of Surgery In Patients With Breast Cancer
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 nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment.
PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.
PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer.
* Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients.
Secondary
* Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients.
* 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.
* Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients.
OUTLINE: Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation, gene expression arrays, and proteomic profiling.
Patients are followed at 24 hours and at 1 week.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.
Primary
* Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer.
* Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients.
Secondary
* Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients.
* 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.
* Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients.
OUTLINE: Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation, gene expression arrays, and proteomic profiling.
Patients are followed at 24 hours and at 1 week.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.
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?: