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临床试验/NCT06751303
NCT06751303招募中不适用

Patient Preferences for Precision Medicine

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Patient decision for use of PARPi therapy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing

研究组 & 干预措施

HRD Tested

Other

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

干预措施: Patients that are HRP are given a decision aid for PARPi use (Other)

结局指标

主要结局

Patient decision for use of PARPi therapy

时间窗: 6 Monhs

The proportion of HRP patients who choose to undergo PARP therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Hopkins

Professor of Oncology

University of Saskatchewan

研究点 (1)

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