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

Sponsor
Xin Wu (Other)
Overall Status
Recruiting
CT.gov ID
NCT05255861
Collaborator
(none)
300
Enrollment
1
Location
34
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy
    Anticipated Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Homologous Recombination Deficiency score [After the ovarian tissue is obtained, an average of 3 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. age ≥ 18 years;

    2. high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;

    3. FIGO stage III or IV;

    4. at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;

    5. CR or PR after chemotherapy;

    6. ECOG 0-1;

    7. sufficient biological samples for HRD score detection;

    8. patients signed informed consent;

    9. good bone marrow function.

    Exclusion Criteria:

    1. incomplete follow-up records of survival information;

    2. unqualified biological sample quality control

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Obstetrics and Gynecology Hospital of Fudan University Shanghai Shanghai China 200000

    Sponsors and Collaborators

    • Xin Wu

    Investigators

    • Principal Investigator: Xin Wu, PHD, The Obstetrics and Gynecology Hospital of Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xin Wu, Department Director, Obstetrics & Gynecology Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT05255861
    Other Study ID Numbers:
    • FUOBGY2021-246
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xin Wu, Department Director, Obstetrics & Gynecology Hospital of Fudan University
    Homologous Recombination Deficiency Score
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Feb 25, 2022