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

NCT ID: NCT06341855

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2026-01-30

Brief Summary

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.

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

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

MRD-ctDNA

Intervention Type: DIAGNOSTIC_TEST

ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.

ctDNA negative

If the ctDNA test result is negative, the subjects will belong to follow-up group

Group Type: OTHER

MRD-ctDNA

Intervention Type: DIAGNOSTIC_TEST

ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.

Interventions

MRD-ctDNA

ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Songling Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the 1st hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiaosen Li Li

Role: primary

xiaosensen@jlu.edu.cn

+8618343116682

Other Identifiers

23K294001

Identifier Type: -

Identifier Source: org_study_id