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NCT06751303: 4PDQ

Patient Preferences for Precision Medicine: Determining Optimal Patient Quality of Life Using PARPi's

Recruiting now NA Last updated 27 December 2024
What this trial tests

NA trial testing Patients that are HRP are given a decision aid for PARPi use in Ovarian Cancer in 100 participants. Currently enrolling.

Timeline
17 September 2023
Primary endpoint
16 September 2026
16 September 2027

Quick facts

Lead sponsorUniversity of Saskatchewan
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment100
Start date17 September 2023
Primary completion16 September 2026
Estimated completion16 September 2027
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Saskatchewan

Who can join

Eligibility, female only, with Ovarian Cancer or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

Other University of Saskatchewan trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06751303.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing