ctDNA Assessment in Endometrial Cancer for Adjuvant Therapy

Condition(s) studied

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

Eligibility

Primary outcome measure(s)

• Disease-Free Survival — Up to 60 months (assessed at 3-month intervals for the first 2 years, 6-month intervals for years 3-5, and annually thereafter)
  Time from date of surgery to date of first documented disease recurrence, progression, or death from any cause, whichever occurs first. Recurrence is defined as local, regional, or distant metastasis confirmed by imaging or histopathology.

Trial sites (1)

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