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Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

China100 participantsStarted 2021-09-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Subjects join the study voluntarily and sign informed consent;
✓. Female subjects are older than 18 years;
✓. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
✓. Life expectancy≥3 months;
✓. 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;
✓. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

Exclusion criteria

✕. Personnel involved in the formulation or implementation of the research plan;
✕. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
✕. 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;
✕. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
✕. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

What they're measuring

Overall Response Rate (ORR)

Timeframe: Through study completion, an average of 1 year

Progression Free Survival (PFS)

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT05044091

SponsorXiaoxiang Chen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09

Contact for this trial

Jing Ni, MD

+86 13327833586 nijingwulin@126.com

View on ClinicalTrials.gov More Ovarian Cancer trials