NCT07681414Active, not recruiting
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 · Last updated 2 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 52 (actual)
- First submitted
- 27 Jun 2026
- Start date
- 27 Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Guizhou Provincial People's Hospital
- Diseases
- Endometrial cancer
- NCT number
- NCT07681414
What you commit to
- Study type: Observational
- Participants enrolled: 52
- From 27 Jun 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guizhou Provincial People's Hospital Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.