Ovarian CancerPROMISENCT06436248
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
An observational study of Ovarian Cancer and BRCA Mutation, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, BRCA Mutation
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Jamie Brower, MS, 215-662-7245, jabrower@pennmedicine.upenn.edu
About this study
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.
Read the 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.
- Conditions
- Ovarian Cancer, BRCA Mutation
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through interviews
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Susan Domchek, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436248
- Sponsor's protocol ID
- UPCC 17824
- Other IDs
- IRB: 855461
- Acronym
- PROMISE
- Status last verified
- Nov 2026
- First submitted
- 29 Apr 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06436248
- Acronym / sponsor ID
- PROMISE / UPCC 17824
- Conditions
- Ovarian Cancer, BRCA Mutation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Memorial Sloan Kettering Cancer Center
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Domchek, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and BRCA Mutation, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Brower, MS (215-662-7245, jabrower@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.