ctDNA Assessment in Endometrial Cancer for Adjuvant Therapy

NCT07681414 | Active Not Recruiting

• 1 other identifier: 2026-144
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival

  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.

  Up to 60 months (assessed at 3-month intervals for the first 2 years, 6-month intervals for years 3-5, and annually thereafter)

Secondary Outcomes (1)

• Overall Survival

  Up to 60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population consists of patients diagnosed with endometrial cancer who underwent radical hysterectomy with bilateral salpingo-oophorectomy and lymph node dissection at Guizhou Provincial People's Hospital, China, between September 2019 and December 2024. All patients had histologically confirmed endometrial cancer and available matched tumor tissue and postoperative plasma samples for NGS and IHC analysis. Patients with stage IV disease or prior neoadjuvant therapy were excluded. The cohort includes FIGO stages I-III, various histologic grades, and all molecular subtypes. A total of 52 patients were enrolled with a median follow-up of 37.5 months.

You may qualify if:

• \. Female patients aged ≥18 years with histologically confirmed endometrial cancer.
• \. Underwent radical hysterectomy with bilateral salpingo-oophorectomy and lymph node dissection.
• \. 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.

You may not qualify if:

• \. Patients with stage IV endometrial cancer or distant metastasis at diagnosis.
• \. Patients who received neoadjuvant chemotherapy, radiotherapy, or targeted therapy prior to surgery.
• \. 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).
• \. Incomplete clinical data or loss to follow-up.

Sponsors & Collaborators

• Guizhou Provincial People's Hospital: lead

Study Sites (1)

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded (FFPE) tumor tissues and peripheral blood samples were collected from all enrolled patients. Blood samples were processed to plasma by centrifugation at 1800g for 10 minutes. Genomic DNA was extracted from FFPE tissues using the QIAamp DNA FFPE Tissue Kit, and cell-free DNA (cfDNA) was extracted from plasma using the QIAamp Circulating Nucleic Acid Kit. DNA samples are stored at -80°C at the Department of Oncology, Guizhou Provincial People's Hospital, and at Geneseeq Technology Inc., Nanjing, China.

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yong Li

  Guizhou Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 2, 2026
• Study Start: June 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)