Ovarian Cancer
Conditions
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 initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.
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 standard. * Exploratory objective 1: To explore how methylation of selective genes correlate with WGS HRD status and efficacy. * Exploratory objective 2: To explore how HRR gene mutations correlate with WGS HRD status and efficacy. * Exploratory objective 3: To set up a harmonized bioinformatic analysis workflow for WGS HRD status.
Interventions
DRUGPARPi
Poly(adenosine diphosphate-ribose) polymerase inhibitor (PARPi)
Sponsors
National Institutes for Food and Drug Control, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lei Li
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to 42 months | Time from first dose of PARPi to disease progression or death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 48 months | Time from first dose of PARPi to death. |
Countries
China
Outcome results
None listed