HRD Status Reference Standard Based on WGS

NCT ID: NCT06490380

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-30

Study Completion Date

2024-06-21

Brief Summary

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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

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* 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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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PARPi

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes for Food and Drug Control, China

OTHER

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HRDref-WGS

Identifier Type: -

Identifier Source: org_study_id

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