Clincosm LogoSign in Get a demo

HRD and Resistance to PAPPi in EOC Patients

Sponsor
Lei Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05310370
Collaborator
(none)
400
Enrollment
1
Location
36
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Testing of homologous recombination deficiency

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correlation Between Homologous Recombination Deficiency Status and Resistance to PARP Inhibitors in Chinese Epithelial Ovarian Cancer Patients
Actual Study Start Date :
Mar 26, 2022
Anticipated Primary Completion Date :
Mar 26, 2024
Anticipated Study Completion Date :
Mar 26, 2025

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [One year]

    Progression-free survival after the start of PARPi

Secondary Outcome Measures

  1. Overall survival [One year]

    Overall survival after the start of PARPi

  2. Severe adverse events [One year]

    Severe adverse events after the start of PARPi

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Lei Li

Investigators

  • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05310370
Other Study ID Numbers:
  • EOC-HRD3
First Posted:
Apr 4, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Apr 4, 2022