An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy

NCT05255861 | Unknown

• 1 other identifier: FUOBGY2021-246
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.

Conditions

Ovarian Cancer

Keywords

Homologous Recombination Deficiency Score

Outcome Measures

Primary Outcomes (1)

• Homologous Recombination Deficiency score

  Optimize the Homologous Recombination Deficiency scoring algorithm to calculate the Homologous Recombination Deficiency score of each patient's ovarian cancer tissue

  After the ovarian tissue is obtained, an average of 3 year

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese women with ovarian cancer

You may qualify if:

• age ≥ 18 years;
• high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
• FIGO stage III or IV;
• at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;
• CR or PR after chemotherapy;
• ECOG 0-1;
• sufficient biological samples for HRD score detection;
• patients signed informed consent;
• good bone marrow function.

You may not qualify if:

• incomplete follow-up records of survival information;
• unqualified biological sample quality control

Sponsors & Collaborators

• Xin Wu: lead

Study Sites (1)

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

• Xin Wu, PHD

  The Obstetrics and Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wu, PHD

CONTACT

(021)33189900-6529; wuxin_fc@fudan.edu.cn

Ling Qiu, MD

CONTACT

(021)33189900-6529; QiuLingpang@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department Director

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2024
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)