A Training Set for the HRD Model in EOC

NCT04651933 | Unknown

• 1 other identifier: EOC-LOH
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer; BRCA Mutation; Loss of Heterozygosity; Prognosis; Platinum Resistance; Homologous Recombination Deficiency

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 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

  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

Genetic: Homologous recombination deficiency model

Epithelial ovarian cancer patients resistant to platinum based chemotherapy

Genetic: Homologous recombination deficiency model

Interventions

Homologous recombination deficiency model GENETIC

A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)

Epithelial ovarian cancer patients resistant to platinum based chemotherapy; Epithelial ovarian cancer patients sensitive to platinum based chemotherapy

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

Patients with known BRCA1/2 mutation status and 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples from the patients' peripheral blood and tumor tissues.

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

+8613911988831; lileigh@163.com

Ming Wu, M.D.

CONTACT

+8613810224549; wuming@pumch.cn

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: November 26, 2022
• Study Completion: November 26, 2022
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

CN (1)