NCT06341855

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRD-ctDNA	ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.

Timeline

• Start date: 2024-01-25
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

1 site across 1 country: China