A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
1 other identifier
observational
240
1 country
1
Brief Summary
The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). 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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Nov 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2020
CompletedStudy Start
First participant enrolled
November 26, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2022
CompletedMarch 29, 2022
March 1, 2021
1.3 years
November 26, 2020
March 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Homologous recombination deficiency (HRD) score
The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for three types of important molecular mechanism: loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor.
Two years
Secondary Outcomes (2)
Progression-free survival
Five years
Overall survival
Five years
Study Arms (2)
Epithelial ovarian cancer patients sensitive to platinum based chemotherapy
Epithelial ovarian cancer patients resistant to platinum based chemotherapy
Interventions
Evaluation of homologous recombination deficiency score which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST)
Eligibility Criteria
Chinese population with confirmed diagnosis of epithelial ovarian cancer with known targeted gene mutations via a multi-panel testing of 27 genes and known resistance to platinum-based chemotherapy
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lei Lilead
Study Sites (1)
Lei Li
Beijing, Beijing Municipality, 100730, China
Biospecimen
All patients accept evaluation of homologous recombination deficiency model.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Li, M.D.
Peking Union Medical College Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 26, 2020
First Posted
December 3, 2020
Study Start
November 26, 2020
Primary Completion
March 26, 2022
Study Completion
March 26, 2022
Last Updated
March 29, 2022
Record last verified: 2021-03