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

The Correlation Between Homologous Recombination Deficiency Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06242392
Enrollment
250
Registered
2024-02-05
Start date
2024-01-31
Completion date
2026-07-01
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasms

Keywords

Ovarian Neoplasms, homologous recombination deficiency, prognosis, Cost-effectiveness analysis

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.

Interventions

GENETIChomologous recombination deficiency

Homologous Recombination Deficiency (HRD) refers to a disruption or deficiency in the homologous recombination repair (HRR) pathway, which is a crucial mechanism in cells for repairing DNA double-strand breaks (DSBs). This pathway is particularly important for maintaining genomic stability.

Sponsors

Fujian Provincial Hospital
CollaboratorOTHER
Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of PARP inhibitors in the treatment of ovarian cancer2026-5-1Progression-Free Survival (PFS) is used to evaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.

Secondary

MeasureTime frameDescription
cost-effectiveness analysis of using PARP inhibitors to treat cervical cancer2026-5-1The 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.
PARP inhibitors in the treatment of ovarian cancer2026-5-1Overall survival (OS) was used toevaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.

Contacts

Primary ContactJian FC Chen
marsz3@126.com+8615806030009
Backup ContactYang Sun
doctorsunyang@sina.com15959028989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026