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Trial Title:
The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer
NCT ID:
NCT06242392
Condition:
Ovarian Neoplasms
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
Ovarian Neoplasms
homologous recombination deficiency
prognosis
Cost-effectiveness analysis
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Genetic
Intervention name:
homologous recombination deficiency
Description:
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.
Arm group label:
effective group
Arm group label:
ineffective group
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.
Criteria for eligibility:
Study pop:
Patients with Ovarian Cancer who were treated from June 2020 to December 2026 and met the
above inclusion and exclusion criteria
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 31, 2024
Completion date:
July 1, 2026
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06242392