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

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

NCT ID: NCT06341855

Condition: Endometrial Cancer

Conditions: Official terms:
Endometrial Neoplasms
Recurrence

Conditions: Keywords:
MRD
Endometrial Cancer
ctDNA

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: MRD-ctDNA
Description: ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.
Arm group label: ctDNA negative
Arm group label: ctDNA positive

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

Criteria for 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.

Gender: Female

Gender based: Yes

Gender description: Gynaecological cancers

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: the 1st hospital of Jilin University

Address:
City: Chang Chun
Country: China

Status: Recruiting

Contact:
Last name: Xiaosen Li Li

Phone: +8618343116682
Email: xiaosensen@jlu.edu.cn

Start date: January 25, 2024

Completion date: January 30, 2026

Lead sponsor:
Agency: The First Hospital of Jilin University
Agency class: Other

Collaborator:
Agency: Geneplus-Beijing Co. Ltd.
Agency class: Industry

Source: The First Hospital of Jilin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06341855