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HRD Status Reference Standard Based on WGS | Clinical Trials | Clareo Health

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COMPLETEDNCT06490380

HRD Status Reference Standard Based on WGS

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...

Lead sponsor: Lei Li•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Lei Li

Collaborators

National Institutes for Food and Drug Control, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

* 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.

Age

18 - No limit years

Sex

FEMALE

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 8, 2024Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment100

Start dateDec 2022

Last updatedJul 8, 2024

Condition

Locations shown

Lei Li

Beijing, Beijing Municipality

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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