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CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05027828
Collaborator
(none)
50
Enrollment
37
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Apr 30, 2024
    Anticipated Study Completion Date :
    Sep 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patients using olaparib only
    patients using olaparib combined with bevacizumab

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [about 36 months after using PARP inhibitors]

      To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing.

    Secondary Outcome Measures

    1. Overall survival [about over 5 years after using PARP inhibitors]

    2. Objective response rate [36 months after using PARP inhibitors]

      To evaluate the general response of patients with ovarian cancer to PARP inhibitors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Ovarian cancer first diagnosed and treated;

    2. Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;

    3. The stage of the disease is II-IV, and surgery will be performed after evaluation;

    4. Age ≥ 18 years old;

    5. Subjects and their families fully understand the research plan and sign an informed consent form.

    Exclusion Criteria:

    1. Pathologically confirmed as non-epithelial ovarian cancer;

    2. Surgical treatment cannot be performed after evaluation;

    3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;

    4. Patients who do not agree to use clinical first-line targeted drugs;

    5. Severe mental illness;

    6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05027828
    Other Study ID Numbers:
    • XH-21-008
    First Posted:
    Aug 30, 2021
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Aug 30, 2021