Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer (PROMISE)

May 30, 2024 updated by: University of Pennsylvania
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 women's attitudes regarding polygenic risk score (PRS) and early detection assays.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

First, the investigators will conduct qualitative interviews to better understand women's 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) (n=24). 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 (e.g., 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 Act/HIPAA 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 (e.g., 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 women's 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 Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Target population is women, age 25 or over, with likely pathogenic or pathogenic variants in BRCA1 or BRCA2 and no personal history of ovarian cancer or risk-reducing oophorectomy surgery.

Description

Inclusion Criteria:

  • Female, age 25 or older (given that women under this age are not generally recommended to receive BRCA1/2 genetic testing)
  • Completed full sequence or targeted genetic testing with a clinically confirmed BRCA1 or BRCA2 deleterious mutation identified.
  • English-fluent; the surveys and interviews were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.

Exclusion Criteria:

  • Previous receipt of any prophylactic oophorectomy
  • Personal history of ovarian cancer
  • Major psychiatric illness or cognitive impairment that in the judgment of the study investigators would preclude study participation.
  • Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through interviews
Time Frame: 1 year
The investigators will assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through semi-structured interviews and thematic content analyses.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Memorial Sloan Kettering Cancer Center
Susan G. Komen Breast Cancer Foundation

Investigators

  • Principal Investigator: Susan Domchek, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 855461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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