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

NCT ID: NCT06751303

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-17

Study Completion Date

2027-09-16

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer Quality of Life

Keywords

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PARPi HRD testing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HRD Tested

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

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Laura Hopkins

Professor of Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saskatchewan Cancer Center

Saskatoon, S, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Susan Kaban

Role: primary

Other Identifiers

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4118

Identifier Type: -

Identifier Source: org_study_id