Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081003
Status:
COMPLETED
Last Update Posted:
2014-07-23
First Post:
2004-04-07
Brief Title:
Nipple Aspiration Ductal Lavage and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Intraduct Environment A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2005-12
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 Screening tests such as nipple aspiration ductal lavage and breast duct endoscopy may help doctors detect cancer cells early and plan more effective treatment for breast cancer
PURPOSE This clinical trial is studying how well nipple aspiration ductal lavage and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer
PURPOSE This clinical trial is studying how well nipple aspiration ductal lavage and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer defined by family history or prior atypical biopsy
Secondary
Correlate cellular atypia with breast cancer biochemical tumor markers growth factors and genetic and protein markers in these participants
Determine cancer risk and incidence utilizing these methods of screening in these participants
Observe the natural history of atypia in these participants over a total of 10 years
Determine whether these techniques may serve as supplementary tools in future screening of these participants
OUTLINE Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years Participants over 50 years of age undergo nipple aspiration every 18 months for 45 years
Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy
Participants are followed annually for a total of 10 years
PROJECTED ACCRUAL A total of 1000 participants will be accrued for this study within approximately 4 years
Primary
Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer defined by family history or prior atypical biopsy
Secondary
Correlate cellular atypia with breast cancer biochemical tumor markers growth factors and genetic and protein markers in these participants
Determine cancer risk and incidence utilizing these methods of screening in these participants
Observe the natural history of atypia in these participants over a total of 10 years
Determine whether these techniques may serve as supplementary tools in future screening of these participants
OUTLINE Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years Participants over 50 years of age undergo nipple aspiration every 18 months for 45 years
Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy
Participants are followed annually for a total of 10 years
PROJECTED ACCRUAL A total of 1000 participants will be accrued for this study within approximately 4 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-20352 | None | None | None |
| RMNHS-2278 | None | None | None |