Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer

March 25, 2024 updated by: Songling Zhang, The First Hospital of Jilin University
Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

High-risk EC has a higher metastasis and recurrence rate, accounting for only 20% of ECs, but accounting for 48% of tumor-related mortality. The prognosis of high-risk EC patients is still poor after standard treatment. Among the indicators for monitoring the recurrence of high-risk EC, the most commonly used tumor markers are CA125 and HE4, but these markers increase only in extrauterine metastasis and are less sensitive. Tumor tissue biopsy is an invasive operation, which can not reflect heterogeneity. In addition, continuous monitoring can not be achieved by one biopsy. Therefore, more sensitive, personalized and easily monitored markers are needed to predict recurrence and prognosis in order to provide individualized treatment. Patients after surgical treatment may have MRD, which is a potential source of subsequent early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be able to reliably detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. CtDNA-MRD is a reliable predictive biomarker in EC. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial cancer, using individualized customized strategy, according to the mutation sites in tumor pathological tissue NGS detection results, combined with cancer core genes, customized probes for each patient. To explore the feasibility of ctDNA-MRD in monitoring recurrence and evaluating prognosis of high-risk endometrial carcinoma. According to the treatment and non-treatment groups of ctDNA-MRD-positive patients after adjuvant therapy, to explore whether intensive treatment of ctDNA-MRD-positive patients with high-risk endometrial cancer after adjuvant therapy can significantly improve the survival benefits of patients

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

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
    • Jilin
      • Chang Chun, Jilin, China
        • Recruiting
        • the 1st hospital of Jilin University
        • 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

Description

Inclusion Criteria:

  • (1) endometrial carcinoma with high risk of recurrence after radical surgery: stage I G3 endometrioid carcinoma, serous carcinoma, clear cell carcinoma, carcinosarcoma, dedifferentiated / undifferentiated carcinoma, II-IV stage endometrial carcinoma, operable recurrent endometrial carcinoma.

    (2) the physical status (PS) score of the eastern tumor tissue cooperation group (ECOG) was 0 or 1.

    (3) the treatment process should cooperate with the provision of clinicopathological and imaging data needed for the research process.

    (4) cooperate with the follow-up and collect the blood of the clinical curative effect evaluation node, and agree to use the test data for follow-up research and product development.

    (5) after operation, imaging examination showed no evidence of local disease or distant metastasis.

Exclusion Criteria:

  • (1) histological diagnosis of endometrial stromal sarcoma.

    (2) there are contraindications of radiotherapy and chemotherapy.

    (3) any other patients who may have poor compliance with the procedures and requirements of the study have been judged by the researchers.

    (4) designated evaluation methods such as imaging can not be accepted or provided.

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ctDNA positive
If the ctDNA test result is positive, the subjects will be stratified to the treatment group or follow-up group at 1:1.
Diagnostic test: MRD-ctDNA
ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.
Other: ctDNA negative
If the ctDNA test result is negative, the subjects will belong to follow-up group
Diagnostic test: MRD-ctDNA
ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
monitoring recurrence and evaluating prognosis
Time Frame: 2 years
The correlation between ctDNA-MRD status and DFS and 2-year DFS rate before, after, during and after adjuvant therapy.
2 years
Treatment benefit
Time Frame: 2 years
To evaluate whether intensive therapy for ctDNA-MRD-positive patients with high-risk endometrial carcinoma after adjuvant therapy can significantly improve the survival benefits of patients.
2 years

Collaborators and Investigators

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

Sponsor

The First Hospital of Jilin University

Collaborators

Geneplus-Beijing Co. Ltd.

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)

January 25, 2024

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23K294001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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