Status:
COMPLETED
HRD Status Reference Standard Based on WGS
Lead Sponsor:
Lei Li
Collaborating Sponsors:
National Institutes for Food and Drug Control, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was...
Detailed Description
* Primary objective: To establish a HRD status reference standard based on WGS. * Secondary objective: To validate the analytical performance of panel HRD status using WGS HRD status as reference stan...
Eligibility Criteria
Inclusion
- At least 18 years of age at diagnosis
- Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- High-grade serous or high-grade endometroid histological type
- FIGO stage II, III, or IV
- Complete response or partial response following completion of first-line adjuvant chemotherapy
- PARPi administered as first-line maintenance therapy
Exclusion
- First-line surgery not conducted
- Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
- First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
- Genotyping quality-control failed
Key Trial Info
Start Date :
December 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06490380
Start Date
December 30 2022
End Date
June 21 2024
Last Update
July 8 2024
Active Locations (1)
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1
Lei Li
Beijing, Beijing Municipality, China, 100730