HRD Status Reference Standard Based on WGS

NCT06490380 | Completed

• 1 other identifier: HRDref-WGS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  Up to 42 months

Secondary Outcomes (1)

• Overall survival

  Up to 48 months

Interventions

PARPi DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ovarian cancer patients received first-line PARPi maintenance therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead
• National Institutes for Food and Drug Control, China: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 8, 2024
• Study Start: December 30, 2022
• Primary Completion: December 13, 2023
• Study Completion: June 21, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)