Recruiting

PARPi's

Sponsor:

University of Saskatchewan

Code:

NCT06751303

Conditions

Ovarian Cancer

Quality of Life

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Patients that are HRP are given a decision aid for PARPi use

Study Details

Brief 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 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

Study ID

NCT06751303

Start date

Sep 17, 2023

Status verified date

Dec, 2024

Completion date

Sep 16, 2027

Anticipated

Primary completion date

Sep 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: HRD Tested

HRP patients are given a decision aid, while HRD patients are not given a decision.

Interventions

Patients that are HRP are given a decision aid for PARPi use

Study created patient decision aid if the first for HRD tested Ovarian Cancer patients

Primary outcome measure

  • Patient decision for use of PARPi therapy [ Time Frame: 6 Monhs ]

Central Contacts and Locations

Locations

Saskatchewan Cancer Center

Recruiting

Saskatoon, S, Canada, S7V4H4

Contacts

More Information

Sponsor

University of Saskatchewan

Last update posted

Dec 27, 2024

Last verified

Dec, 2024

Keywords

  • PARPi
  • HRD testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2024-12-27.