Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments

August 30, 2023 updated by: Jing Li
Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer after PDS/IDS surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the number of cycles of adjuvant treatment after PDS.

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 Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Advanced ovarian cancer patients

Description

Inclusion Criteria:

  1. ≥ 18 years old.
  2. Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination.
  3. The participant has read and fully understands the patient information, and has signed the informed consent form.
  4. The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -

Exclusion Criteria:

  1. Other tumors have been detected within the last 5 years.
  2. Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants.
  3. Patients was deemed unsuitable to participate in this study by other researchers.
  4. Patients who have previously received neoadjuvant chemotherapy or targeted therapy.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 years DFS rate
Time Frame: 2 years
The recurrence rate of patients at two years after surgery
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 2 years
Disease-free survival
2 years

Collaborators and Investigators

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

Sponsor

Jing Li

Collaborators

Nanjing Shihejiyin Technology, Inc.

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 (Actual)

August 1, 2022

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Estimated)

September 6, 2023

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SunYatsen202309

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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