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

April 17, 2024 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newly-diagnosed and treated patients with high-grade serous ovarian cancer who will receive PARP inhibitors as first-line maintenance therapy after surgery and traditional chemotherapy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients using olaparib only
patients using olaparib combined with bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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.
about 36 months after using PARP inhibitors

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: about over 5 years after using PARP inhibitors
about over 5 years after using PARP inhibitors
Objective response rate
Time Frame: 36 months after using PARP inhibitors
To evaluate the general response of patients with ovarian cancer to PARP inhibitors
36 months after using PARP inhibitors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-21-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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