Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429988
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2007-01-30
Brief Title:
Study of Ductal Lavage in Women at High Risk for Breast Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Ductal Lavage to Monitor and Treat High Risk Women
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RATIONALE Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer
PURPOSE This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer
PURPOSE This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer
Secondary
Determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants
Analyze the nipple aspirate fluid from these participants for specific and global protein signatures
Determine the replicability of markers in serial assays of these participants
Determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy
OUTLINE This is a multicenter study
Participants undergo nipple aspirate fluid and ductal lavage fluid collection Fluid samples are analyzed using cytological analysis immunohistochemistry fluorescent in situ hybridization or in situ polymerase chain reaction Protein patterns are identified using mass spectrometry
Participants found to have atypia undergo repeat lavage at 3-6 months and 1 year Participants with normal fluid samples undergo repeat lavage at 1 year
PROJECTED ACCRUAL A total of 30 participants will accrued for this study within 2-3 months
Primary
Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer
Secondary
Determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants
Analyze the nipple aspirate fluid from these participants for specific and global protein signatures
Determine the replicability of markers in serial assays of these participants
Determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy
OUTLINE This is a multicenter study
Participants undergo nipple aspirate fluid and ductal lavage fluid collection Fluid samples are analyzed using cytological analysis immunohistochemistry fluorescent in situ hybridization or in situ polymerase chain reaction Protein patterns are identified using mass spectrometry
Participants found to have atypia undergo repeat lavage at 3-6 months and 1 year Participants with normal fluid samples undergo repeat lavage at 1 year
PROJECTED ACCRUAL A total of 30 participants will accrued for this study within 2-3 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-TEMP01 | None | None | None |