Recruiting

Observational Study

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06436248

Conditions

Ovarian Cancer

BRCA Mutation

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Study Details

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 women's attitudes regarding polygenic risk score (PRS) and early detection assays.

Conditions

Ovarian Cancer

BRCA Mutation

Study ID

NCT06436248

Start date

Jul 1, 2024

Status verified date

Oct, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Oct 30, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.