HRD and Resistance to PAPPi in EOC Patients

NCT05310370 | Unknown

• 1 other identifier: EOC-HRD3
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Conditions

Epithelial Ovarian Cancer; Homologous Recombination Deficiency; Homologous Recombination Repair Gene Mutation; Poly(ADP-ribose) Polymerase Inhibitor; Drug Resistance; Progression-free Survival; Overall Survival

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival after the start of PARPi

  One year

Secondary Outcomes (2)

• Overall survival

  One year

• Severe adverse events

  One year

Interventions

Testing of homologous recombination deficiency GENETIC

A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

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

Chinese cohort confirmed of epithelial ovarian cancer after the complete or partial remission of disease

You may qualify if:

• Aged 18 years or older
• Pathological confirmation of epithelial ovarian cancer
• With available tumor tissues
• Given consents to participate the study
• With detailed follow-up outcomes

You may not qualify if:

• Declining to accept PARPi as maintenance therapy after the major treatment for cancer

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; 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 Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831; lileigh@163.com

Study Design

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

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 4, 2022
• Study Start: March 26, 2022
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2025
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (1)