Endometrial CancerNCT07681414
ctDNA Assessment in Endometrial Cancer for Adjuvant Therapy
An observational study of Endometrial Cancer, run by Guizhou Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative ctDNA Assessment in Endometrial Cancer Beyond Integrated Genomic Risk Models, Reshaping Precision Decisions for Adjuvant Therapy
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:
Read more
- 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
Read the detailed description
Endometrial cancer is one of the most common gynecological malignancies worldwide, with rising incidence and mortality. Traditional prognostic assessment based on clinicopathological factors such as FIGO stage, histologic grade, and hormone receptor status has limitations in accurately stratifying recurrence risk, leading to overtreatment in some patients and undertreatment in others. The TCGA molecular classification has refined prognostic evaluation, but challenges remain due to tumor heterogeneity.
This is a retrospective observational cohort study conducted at the Department of Oncology, Guizhou Provincial People's Hospital, China. A total of 52 patients who underwent radical hysterectomy with bilateral salpingo-oophorectomy and lymph node dissection for endometrial cancer between September 2019 and December 2024 were enrolled. All participants had available formalin-fixed paraffin-embedded (FFPE) tumor tissues and postoperative plasma samples.
Tumor tissue genomic DNA was extracted using the QIAamp DNA FFPE Tissue Kit. Plasma cell-free DNA (cfDNA) was extracted and purified using the QIAamp Circulating Nucleic Acid Kit. Genomic DNA from peripheral blood leukocytes served as the normal control. Comprehensive genomic profiling was performed using a targeted next-generation sequencing (NGS) panel covering 425 cancer-related genes (GeneseeqPrime™). Libraries were sequenced on the DNBSEQ-T7 platform. Immunohistochemical analysis was conducted to assess p53 expression and hormone receptor status.
The Clinico-Genomic Risk Score (CGRS) model was constructed based on TCGA binary decision principles, incorporating four prognostic variables: POLE hypermutation status, TP53 mutation status, FIGO grade, and hormone receptor status. POLE hypermutation serves as the primary stratification indicator. Patients with POLE hypermutation are classified into the low-risk group. For patients without POLE hypermutation, secondary stratification is based on TP53 mutation status. Patients with TP53 mutations are classified into the high-risk group. For patients without POLE hypermutation and with TP53 wild-type, final classification is determined by FIGO grade and HR status. Only patients with FIGO Grade 1 and HR-positive status are classified into the low-risk group; all others are included in the high-risk group.
All patients are followed according to a standardized schedule: imaging re-examination at 4 weeks post-treatment; every 3 months within 1-2 years; every 6 months within 3-5 years; and annually after 5 years. Disease-free survival (DFS), defined as time from surgery to disease recurrence or progression, is the primary endpoint. Overall survival (OS) is the secondary endpoint.
Statistical analyses include Kaplan-Meier survival curves, log-rank tests, and univariable and multivariable Cox proportional hazards regression models to identify independent prognostic factors. External validation of the CGRS model is performed using the TCGA endometrial cancer cohort. All statistical tests are two-sided, with significance set at P < 0.05. Analyses are performed using R software (version 4.4.3).
This study was approved by the Ethics Committee of Guizhou Provincial People's Hospital
- Conditions
- Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Time from date of surgery to date of death from any cause. Patients alive at last follow-up are censored.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start27 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guizhou Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Li, Principal investigator, Guizhou Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681414
- Sponsor's protocol ID
- 2026-144
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to patient privacy and genomic data confidentiality concerns. De-identified summary results will be made available in the article and supplementary materials. Requests for additional data may be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative ctDNA Assessment in Endometrial Cancer Beyond Integrated Genomic Risk Models, Reshaping Precision Decisions for Adjuvant Therapy
- ClinicalTrials.gov ID
- NCT07681414
- Acronym / sponsor ID
- 2026-144
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Guizhou Provincial People's HospitalUniversity, hospital or other
- Study start
- 27 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Endometrial cancer is one of the most common gynecological malignancies worldwide, with rising incidence and mortality. Traditional prognostic assessment based on clinicopathological factors such as FIGO stage, histologic grade, and hormone receptor status has limitations in accurately stratifying recurrence risk, leading to overtreatment in some patients and undertreatment in others. The TCGA molecular classification has refined prognostic evaluation, but challenges remain due to tumor heterogeneity.
This is a retrospective observational cohort study conducted at the Department of Oncology, Guizhou Provincial People's Hospital, China. A total of 52 patients who underwent radical hysterectomy with bilateral salpingo-oophorectomy and lymph node dissection for endometrial cancer between September 2019 and December 2024 were enrolled. All participants had available formalin-fixed paraffin-embedded (FFPE) tumor tissues and postoperative plasma samples.
Tumor tissue genomic DNA was extracted using the QIAamp DNA FFPE Tissue Kit. Plasma cell-free DNA (cfDNA) was extracted and purified using the QIAamp Circulating Nucleic Acid Kit. Genomic DNA from peripheral blood leukocytes served as the normal control. Comprehensive genomic profiling was performed using a targeted next-generation sequencing (NGS) panel covering 425 cancer-related genes (GeneseeqPrime™). Libraries were sequenced on the DNBSEQ-T7 platform. Immunohistochemical analysis was conducted to assess p53 expression and hormone receptor status.
The Clinico-Genomic Risk Score (CGRS) model was constructed based on TCGA binary decision principles, incorporating four prognostic variables: POLE hypermutation status, TP53 mutation status, FIGO grade, and hormone receptor status. POLE hypermutation serves as the primary stratification indicator. Patients with POLE hypermutation are classified into the low-risk group. For patients without POLE hypermutation, secondary stratification is based on TP53 mutation status. Patients with TP53 mutations are classified into the high-risk group. For patients without POLE hypermutation and with TP53 wild-type, final classification is determined by FIGO grade and HR status. Only patients with FIGO Grade 1 and HR-positive status are classified into the low-risk group; all others are included in the high-risk group.
All patients are followed according to a standardized schedule: imaging re-examination at 4 weeks post-treatment; every 3 months within 1-2 years; every 6 months within 3-5 years; and annually after 5 years. Disease-free survival (DFS), defined as time from surgery to disease recurrence or progression, is the primary endpoint. Overall survival (OS) is the secondary endpoint.
Statistical analyses include Kaplan-Meier survival curves, log-rank tests, and univariable and multivariable Cox proportional hazards regression models to identify independent prognostic factors. External validation of the CGRS model is performed using the TCGA endometrial cancer cohort. All statistical tests are two-sided, with significance set at P < 0.05. Analyses are performed using R software (version 4.4.3).
This study was approved by the Ethics Committee of Guizhou Provincial People's Hospital
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-Free Survival
Time frame: 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.
1 secondary outcome
Overall Survival
Time frame: Up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to patient privacy and genomic data confidentiality concerns. De-identified summary results will be made available in the article and supplementary materials. Requests for additional data may be directed to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Li principal investigator
Guizhou Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Guizhou Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (time frame: Up to 60 months (assessed at 3-month intervals for the first 2 years, 6-month intervals for years 3-5, and annually thereafter)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.