Ovarian Cancer4PDQNCT06751303
Patient Preferences for Precision Medicine: Determining Optimal Patient Quality of Life Using PARPi's
A study testing Patients that are HRP are given a decision aid for PARPi use in people with Ovarian Cancer and Quality of Life, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Quality of Life
- What is being tested?
- Patients that are HRP are given a decision aid for PARPi use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2023to 16 Sep 2027
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Known or suspected stage 3/4 high grade serous or endometrioid ovarian cancer Able to provide oral consent and complete questionnaires in English as per study protocol
Who cannot join
- Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Saskatchewan Cancer Center
Saskatoon, S, S7V4H4
Susan Kaban, 306-655-2691, susan.kaban@saskcancer.ca
About this study
Official title: Patient Preferences for Precision Medicine
Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib.
We hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.
- Conditions
- Ovarian Cancer, Quality of Life
- Being tested
- Patients that are HRP are given a decision aid for PARPi use
- Keywords
- PARPi, HRD testing
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients that are HRP are given a decision aid for PARPi useOther
Study created patient decision aid if the first for HRD tested Ovarian Cancer patients
| Study group | Role | What they receive |
|---|---|---|
| HRD Tested | Other | HRP patients are given a decision aid, while HRD patients are not given a decision. Receives: Other: Patients that are HRP are given a decision aid for PARPi use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient decision for use of PARPi therapy
The proportion of HRP patients who choose to undergo PARP therapy.
Measured: 6 Monhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start17 Sep 2023
- Primary completion16 Sep 2026 (estimated)
- Study completion16 Sep 2027 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pragmatic trial which offers HRD testing and for patients HRProficient, a patient decision aid to help them decide whether niraparib is right for them. Whatever they decide, we followup with QoL questionnaires and assessment of time to progression.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Hopkins, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751303
- Sponsor's protocol ID
- 4118
- Acronym
- 4PDQ
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preferences for Precision Medicine
- ClinicalTrials.gov ID
- NCT06751303
- Acronym / sponsor ID
- 4PDQ / 4118
- Conditions
- Ovarian Cancer, Quality of Life
- Keywords
- PARPi, HRD testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 27 Dec 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.
Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib.
We hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pragmatic trial which offers HRD testing and for patients HRProficient, a patient decision aid to help them decide whether niraparib is right for them. Whatever they decide, we followup with QoL questionnaires and assessment of time to progression.
| Arm | Type | Receives |
|---|---|---|
| HRD Tested | Other | Other: Patients that are HRP are given a decision aid for PARPi useHRP patients are given a decision aid, while HRD patients are not given a decision. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Known or suspected stage 3/4 high grade serous or endometrioid ovarian cancer Able to provide oral consent and complete questionnaires in English as per study protocol
Key exclusion criteria (1 listed)
- Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients that are HRP are given a decision aid for PARPi useStudy created patient decision aid if the first for HRD tested Ovarian Cancer patients | Other | HRD Tested |
Primary outcome
Patient decision for use of PARPi therapy
Time frame: 6 Monhs
The proportion of HRP patients who choose to undergo PARP therapy.
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 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients that are HRP are given a decision aid for PARPi use in people with Ovarian Cancer and Quality of Life, run by University of Saskatchewan at 1 site in Canada.
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 1 inclusion and 1 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 27 Dec 2024. 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient decision for use of PARPi therapy (time frame: 6 Monhs). 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 27 Dec 2024.