Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117663
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2005-06-30
Brief Title:
Radiologic Evaluation and Breast Density READ
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of Hormone Replacement Therapy HRT on Mammography Assessments and Breast Density
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The purpose of this study is to determine whether cessation of hormone replacement therapy for one or two months before a screening mammogram will improve its performance by decreasing breast density
Detailed Description:
This randomized controlled trial is designed to test whether short-term 1-2 months HRT cessation will sufficiently lower breast density to decrease the proportion of women who receive a recommendation for additional evaluation following a screening mammogram and to examine whether there is a trend by duration of cessation The study is being conducted at Group Health Cooperative a managed health care organization in western Washington State with an organized breast cancer screening program We are recruiting 1500 women and will randomize women to one of three HRT arms 1 cessation two months before the screening mammogram 2 cessation one month before and 3 continued HRT use We are using a computer-assisted method to measure mammographic breast density continuously Mammography recall rates are being determined from an expert radiologist review of the mammograms blinded to HRT status
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