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Clinical Trials/NCT04651933
NCT04651933UnknownNot Applicable

A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer

Lei Li1 site in 1 country200 target enrollmentStarted: November 26, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Homologous recombination deficiency (HRD) score

Study Overview

Brief Summary

A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Exclusion Criteria

  • Not meeting all of the inclusion criteria

Outcomes

Primary Outcomes

Homologous recombination deficiency (HRD) score

Time Frame: Two years

The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for loss of heterozygosity (LOH), and the minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor

Secondary Outcomes

  • Progression-free survival(Five years)
  • Overall survival(Five years)

Investigators

Sponsor
Lei Li
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Study Sites (1)

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