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A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04651920
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Epithelial Ovarian Cancer Chinese Homologous Recombination Deficiency BRCA1 Mutation BRCA2 Mutation Prognosis Homologous Recombination Genes Genetic: Evaluation of homologous recombination deficiency score

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
Actual Study Start Date : November 26, 2020
Estimated Primary Completion Date : November 26, 2022
Estimated Study Completion Date : November 26, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Epithelial ovarian cancer patients sensitive to platinum based chemotherapy Genetic: Evaluation of homologous recombination deficiency score
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)
Epithelial ovarian cancer patients resistant to platinum based chemotherapy Genetic: Evaluation of homologous recombination deficiency score
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 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.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Five years ]
    Progression-free survival in recruited patients

  2. Overall survival [ Time Frame: Five years ]
    Overall survival in recruited patients


Biospecimen Retention:   Samples With DNA
All patients accept evaluation of homologous recombination deficiency model.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04651920


Contacts
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Contact: Lei Li, M.D. +8613911988831 lileigh@163.com
Contact: Ming Wu, M.D. +8613810224549 wuming@pumch.cn

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    8613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
More Information
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04651920    
Other Study ID Numbers: EOC-HRD2
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type