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ACTIVE NOT RECRUITING
NCT07681414

ctDNA Assessment in Endometrial Cancer for Adjuvant Therapy

Sponsor: Guizhou Provincial People's Hospital

View on ClinicalTrials.gov

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

Official title: Postoperative ctDNA Assessment in Endometrial Cancer Beyond Integrated Genomic Risk Models, Reshaping Precision Decisions for Adjuvant Therapy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

52

Start Date

2026-06-27

Completion Date

2026-12-31

Last Updated

2026-07-02

Healthy Volunteers

No

Locations (1)

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China