Clinical trial · Observational
ctDNA Assessment in Endometrial Cancer for Adjuvant Therapy
Postoperative ctDNA Assessment in Endometrial Cancer Beyond Integrated Genomic Risk Models, Reshaping Precision Decisions for Adjuvant Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-Free Survival
- timeFrame
- Up to 60 months (assessed at 3-month intervals for the first 2 years, 6-month intervals for years 3-5, and annually thereafter)
- description
- 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.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to 60 months
- description
- Time from date of surgery to date of death from any cause. Patients alive at last follow-up are censored.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Female patients aged ≥18 years with histologically confirmed endometrial cancer. 2\. Underwent radical hysterectomy with bilateral salpingo-oophorectomy and lymph node dissection. 3\. Available formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. 4. Available postoperative peripheral blood samples for plasma ctDNA analysis. 5. Complete clinicopathological data and follow-up records. Exclusion Criteria: * 1\. Patients with stage IV endometrial cancer or distant metastasis at diagnosis. 2\. Patients who received neoadjuvant chemotherapy, radiotherapy, or targeted therapy prior to surgery. 3\. Insufficient or poor-quality tissue or plasma samples for NGS analysis. 4. History of other primary malignancies within the past 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 5\. Incomplete clinical data or loss to follow-up.
References
Publications (0)
Data not yet available