Skip to main content
OpenTrials
Completed

NCT Number: NCT06490380

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lei Li

Beijing, Beijing Municipality, 100730, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PARPi

Drug

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

Primary outcomes

  1. Progression-free survival

    Time frame: Up to 42 months

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

Secondary outcomes

  1. Overall survival

    Time frame: Up to 48 months

    Time from first dose of PARPi to death.

Sponsors and collaborators

Lead sponsor

Lei Li

Other

Collaborators

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

Registry information

Official study title

A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.