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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341855
• Other study ID #: 23K294001
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: January 30, 2026

Study information

• Verified date: March 2024
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Recurrence

Intervention

Diagnostic Test:
• MRD-ctDNA
ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.

Locations

Country	Name	City	State
China	the 1st hospital of Jilin University	Chang Chun	Jilin

Sponsors (2)

Lead Sponsor	Collaborator
The First Hospital of Jilin University	Geneplus-Beijing Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	monitoring recurrence and evaluating prognosis	The correlation between ctDNA-MRD status and DFS and 2-year DFS rate before, after, during and after adjuvant therapy.	2 years
Primary	Treatment benefit	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