Homologous Recombination Deficiency Associated With Response to Poly (ADP-ribose) Polymerase Inhibitors in Ovarian Cancer Patients: the First Real-word Evidence From China
| Registry | NCT05044091, acronym HOPEI |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Xiaoxiang Chen (Other) |
| Conditions | Ovarian Cancer, HRD, PARP Inhibitor |
| Interventions | PARP inhibitor (Drug) |
| Dates | start 2021-09-15 (estimated), primary completion 2022-09-01 (estimated), completion 2023-09-01 (estimated), first posted 2021-09-14, last updated 2021-09-14 |
| Locations | 1 site in China |
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Homologous recombination deficiency (HRD) is an important molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. However, the proportion of HRD positive in real world and relationship of HRD status with PARPi in Chinese ovarian cancer patients remains unknown.
This study intends to perform HRD testing of ovarian cancer in real world from China and correlate HRD status and clinical characteristics with therapeutic outcomes.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ovarian/fallopian tube/primary peritoneal cancer patients | Drug: PARP inhibitor | ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: 1. Subjects join the study voluntarily and sign informed consent; 2. Female subjects are older than 18 years; 3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2; 4. Life expectancy≥3 months; 5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous or endometrioid histology; 6. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks. Exclusion Criteria: 1. Personnel involved in the formulation or implementation of the research plan; 2. Patient participated in other clinical trails using other experimental drugs at the same time as the study; 3. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ; 4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
| Facility | City | Country | Status |
|---|---|---|---|
| Xiaoxiang Chen, MD,PhD | Nanjing, Jiangsu | China |