Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436248
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-03
First Post:
2024-04-29
Brief Title:
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
PROMISE
Brief Summary:
The overall goal of the Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer PROMISE study is to better understand how women may incorporate both polygenic risk score PRS and novel early detection strategies in their decisions regarding cancer screening and risk reducing surgery This study will conduct qualitative interviews to better understand womens attitudes regarding polygenic risk score PRS and early detection assays
Detailed Description:
First the investigators will conduct qualitative interviews to better understand womens attitudes regarding polygenic risk score PRS and early detection assays Participants will include English-speaking adult women with BRCA1 or BRCA2 pathogenic variants PV who have not previously undergone risk-reducing salpingo-oophorectomy RRSO n24 Interviews will be led by a trained member of the study team using a semi-structured interview guide in order to review definitions of test characteristics eg sensitivity specificity and discuss participants understanding and perceived importance of such test characteristics and the potential impact of polygenic risk score PRS and early detection assay results in informing their cancer prevention decisions Interviews will be audio-recorded utilizing Zoom audio recording and transcribed using 3Play Media transcription service Health Insurance Portability and Accountability ActHIPAA compliant The investigators will lead analysis of the de-identified transcripts through a process of independent and collaborative thematic content analysis an established method in qualitative research in order to establish key themes related to clarifying participants willingness and concerns eg discomfort with test characteristics perceived ambiguity for adopting these emerging tests
Findings from these qualitative interviews will also inform development of hypothetical scenarios that will then be evaluated in a subsequent questionnaire administered to 175-200 English-speaking adult women with BRCA1 or BRCA2 Pathogenic Variants who have not previously undergone risk-reducing oophorectomy or risk-reducing mastectomy The objective of this survey will be to further evaluate womens decision-making responses to hypothetical polygenic risk score PRS and early detection assays and to determine if there are test characteristics and result thresholds that appear meaningful Details of this questionnaire and its administration will be included in a future amendment to this current protocol
Results from year 1 will be used to develop patient materials to use in providing individualized polygenic risk score PRS and early detection assay results back to patients in years 2-3 Taken together investigators hope that this project will provide an estimate on the absolute magnitude of risk which would result in risk reducing surgery within a year and how a negative early detection assay might modulate such action
Findings from these qualitative interviews will also inform development of hypothetical scenarios that will then be evaluated in a subsequent questionnaire administered to 175-200 English-speaking adult women with BRCA1 or BRCA2 Pathogenic Variants who have not previously undergone risk-reducing oophorectomy or risk-reducing mastectomy The objective of this survey will be to further evaluate womens decision-making responses to hypothetical polygenic risk score PRS and early detection assays and to determine if there are test characteristics and result thresholds that appear meaningful Details of this questionnaire and its administration will be included in a future amendment to this current protocol
Results from year 1 will be used to develop patient materials to use in providing individualized polygenic risk score PRS and early detection assay results back to patients in years 2-3 Taken together investigators hope that this project will provide an estimate on the absolute magnitude of risk which would result in risk reducing surgery within a year and how a negative early detection assay might modulate such action
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