Clinical Trial

ctDNA Assessment in Endometrial Cancer for Adjuvant Therapy

Active, Not Recruiting
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Summary
The goal of this observational study is to evaluate whether combining postoperative circulating tumor DNA (ctDNA) testing with a novel genomic risk model can better predict recurrence risk and guide adjuvant therapy decisions in patients with endometrial cancer. The main questions it aims to answer are: * Can the Clinico-Genomic Risk Score (CGRS) model, which integrates POLE hypermutation, TP53 mutation, FIGO grade, and hormone receptor status, effectively stratify patients into different prognosis groups? * Is postoperative ctDNA positivity associated with a higher risk of disease recurrence? * Does combining CGRS and ctDNA provide more accurate risk assessment than either alone? Researchers will compare the high-risk and low-risk groups defined by the CGRS model, as well as ctDNA-positive and ctDNA-negative groups, to see if these markers can identify patients who need more intensive or less intensive treatment. Participants will: * Undergo radical hysterectomy and lymph node dissection as their standard surgical treatment * Provide blood samples and tumor tissue samples for genetic testing (next-generation sequencing) and immunohistochemistry after surgery * Receive routine follow-up care with imaging examinations at regular intervals (every 3 months for the first 2 years, every 6 months for years 3-5, and annually thereafter) to monitor for recurrence
Trial Details
NCT Number NCT07681414
Lead Sponsor Guizhou Provincial People's Hospital
Conditions Endometrial Cancer
Enrollment 52 participants
Start Date 2026-06-27
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-02