Clinical trial · Observational
HRD Status Reference Standard Based on WGS
A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PARPi | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Up to 42 months
- description
- Time from first dose of PARPi to disease progression or death, whichever occurs first.
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- Up to 48 months
- description
- Time from first dose of PARPi to death.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available