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ctDNA Assessment in Endometrial Cancer for Adjuvant Therapy

NCT07681414 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2026-07-02

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Guizhou Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Yong Li · Guizhou Provincial People's Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-27
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07681414 on ClinicalTrials.gov