HRD Status Reference Standard Based on WGS

Lei Li100 enrolled

Overview

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.

* 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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Ovarian Cancer

Interventions

PARPiDRUG

Poly(adenosine diphosphate-ribose) polymerase inhibitor (PARPi)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Lei Li

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Progression-free survival

Time from first dose of PARPi to disease progression or death, whichever occurs first.

Time frame: Up to 42 months

Secondary Outcomes

Overall survival

Time from first dose of PARPi to death.

Time frame: Up to 48 months

Data from ClinicalTrials.gov

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