The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer

Not yet recruiting

• Conditions: Ovarian Neoplasms
• Interventions: Genetic: homologous recombination deficiency

• Registration Number: NCT06242392
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

Clinicopathological data were collected from ovarian cancer patients treated with PARP inhibitors, with follow-up imaging conducted before and after treatment. The efficacy was evaluated according to RECIST criteria, comparing the correlation between different HRD statuses and the efficacy of PARP inhibitors in ovarian cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study Start: 2024-01-31
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Primary Completion: 2026-05-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Patients diagnosed with ovarian cancer (any histological type) and possessing complete pathological hematoxylin and eosin (HE) stained slides and paraffin-embedded tissue blocks.
• Patients must be 18 years of age or older.
• Patients should not have concurrent multiple primary cancers.
• Patients must undergo an MRI or CT scan prior to starting treatment.
• According to RECIST (Response Evaluation Criteria In Solid Tumors) criteria, patients must have at least one measurable lesion.
• Participants must provide informed consent, voluntarily cooperate with clinical follow-up, and sign an informed consent form.

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Exclusion Criteria

• Patients who do not have accessible tumor tissue required for Homologous Recombination Deficiency (HRD) testing.
• Patients whose clinical records are incomplete, making it impossible to effectively compare treatment efficacy.
• Patients who are lost to follow-up and for whom subsequent treatment outcomes cannot be tracked.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
effective group	homologous recombination deficiency	The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria, patients who were evaluated as complete remission, partial remission and stable disease were included in the effective group. Patients assessed as having progressive disease were included in the treatment-refractory group.
ineffective group	homologous recombination deficiency	The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria. Patients assessed as having progressive disease were included in the ineffective group.

Primary Outcome Measures

Name	Time	Method
Efficacy of PARP inhibitors in the treatment of ovarian cancer	2026-5-1	Progression-Free Survival (PFS) is used to evaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.

Secondary Outcome Measures

Name	Time	Method
PARP inhibitors in the treatment of ovarian cancer	2026-5-1	Overall survival (OS) was used toevaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.
cost-effectiveness analysis of using PARP inhibitors to treat cervical cancer	2026-5-1	The main economic outcome is the ICER.Health benefits were expressed as life years (LYs), and quality-adjusted life-years (QALYs) gained. The ICER was calculated by dividing the incremental cost difference between the two strategies, by the incremental difference in health outcomes (LYs and QALYs). Probabilistic Sensitivity Analysis (PSA) was performed to assess the impact of uncertainty around the key parameters of the model on the ICER. A second-order Monte Carlo simulation with 1000 iterations was used to run replicated outcomes. The normal distributions used for costs, utility and reimbursement ratio were carried to the specific limits.