Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534424
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA12 Mutation CARE Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The caRe Study Clinical Application of Refined Risk Estimates
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates the impact of enhanced risk assessments on knowledge perceptions and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation BRCA12 mutation carriers have a much higher risk of developing breast and ovarian cancer Due to the high risk of cancer mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy Doctors want to learn if a more personalized risk assessment impacts the patients risk perceptions and comfort with decision-making around cancer prevention behaviors
Detailed Description:
PRIMARY OBJECTIVES
I To deploy tools for delivering enhanced genetic risk predictions based on BRCA12 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on genetic knowledge risk perceptions and decisional conflict regarding cancer prevention decision-making
II To perform long-term follow-up of individuals in the randomized controlled trial RCT to determine if there are differences in satisfaction decision-making and outcomes in individuals who received standard versus enhanced genetic risk predictions over time
OUTLINE Patients undergo collection of blood or mouthwash samples Patients are then randomized to 1 of 2 arms
ARM I Patients undergo genotyping with enhanced risk assessment on study 4 to 8 weeks later patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling
ARM II 4-8 weeks later patients receive a standard follow-up phone call
After completion of study intervention patients are followed up for 2 years
I To deploy tools for delivering enhanced genetic risk predictions based on BRCA12 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on genetic knowledge risk perceptions and decisional conflict regarding cancer prevention decision-making
II To perform long-term follow-up of individuals in the randomized controlled trial RCT to determine if there are differences in satisfaction decision-making and outcomes in individuals who received standard versus enhanced genetic risk predictions over time
OUTLINE Patients undergo collection of blood or mouthwash samples Patients are then randomized to 1 of 2 arms
ARM I Patients undergo genotyping with enhanced risk assessment on study 4 to 8 weeks later patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling
ARM II 4-8 weeks later patients receive a standard follow-up phone call
After completion of study intervention patients are followed up for 2 years
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