Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT00255060
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2005-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-07
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:
To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.
Detailed Description:
General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.
The following are our specific goals in this endeavor;
1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
2. To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a \>10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.
The following are our specific goals in this endeavor;
1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
2. To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a \>10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.
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?: