Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04474834
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-21
First Post:
2020-07-14
Brief Title:
GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake Risk Reducing Surgery or Intensive Imaging Surveillance
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake Risk Reducing Surgery or Intensive Imaging Surveillance a Study to Determine If a Polygenic Risk Score Influences the Decision Making Options Amongst High Risk Women GENRE 2
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
GENRE2
Brief Summary:
The primary aim of this study is to determine if the addition of an individual polygenic risk score PRS in addition to the Breast Cancer Risk Assessment Tool BCRAT or Tyrer-Cuzick IBIS score will aid women at risk of breast cancer in making a decision to take or not take medications to prevent breast cancer
Detailed Description:
This is a minimal risk prospective multisite study with a single arm incorporating the PRS into a standard breast cancer risk reduction consultation followed by annual surveys over 10 years to determine if and how the availability of the PRS influenced patient decisions regarding preventive medicine and medication compliance Because women know beforehand that the PRS is pending study participants will be advised that a final decision to take preventive medicine must be deferred until after the PRS results are made available Nevertheless a survey of understanding of risk and benefit and assessment of willingness to take preventive medicine will be done prior to receiving the PRS results and then another survey will be completed after receiving the PRS score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None