Endometrial NeoplasmsEndoMethy-VNCT07298707
Cervical Cytology DNA Methylation for Endometrial Lesion Screening and Follow-up
An observational study of Endometrial Neoplasms and DNA Methylation, run by Peking Union Medical College Hospital.
Trial summary
The goal of this observational study is to evaluate the accuracy of a novel molecular test for screening and monitoring endometrial lesions in women at medium-to-high risk for endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms, DNA Methylation, Cervical Smears
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 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 multicenter, prospective cohort study aims to enroll approximately 3,500 adult women in China who are at medium-to-high risk for endometrial cancer according to Chinese clinical consensus guidelines. The study population specifically includes two groups: 1) women who are scheduled for a diagnostic hysteroscopy due to these risk factors, and 2) women who are currently undergoing conservative treatment (such as progesterone therapy or endometrial ablation) for existing endometrial lesions and have not received chemotherapy. All participants must have an intact cervix and be willing to participate in follow-up assessments. Participants will be followed for up to 12 months, with the enrollment target set to observe at least 20 endpoint events (diagnosis of endometrial intraepithelial neoplasia or invasive cancer).
Who may be able to join
- Participants must be 18 years of age or older.
- Participants must possess medium-to-high risk factors for endometrial cancer as defined by Chinese consensus guidelines and are scheduled for hysteroscopic evaluation; OR are currently undergoing conservative treatment (e.g., progesterone therapy or endometrial ablation) for endometrial lesions, and have not received chemotherapy.
- Participants must be capable and willing to provide written informed consent.
- Participants must be willing to undergo at least one follow-up assessment within 1 year.
- Participants must have an intact cervix (a history of LEEP or conization is acceptable).
Who cannot join
- Current treatment for any gynecologic malignancy other than endometrial cancer.
- Current or untreated cervical, vaginal, or vulvar intraepithelial neoplasia or carcinoma.
- History of total or subtotal hysterectomy, trachelectomy, radical trachelectomy, or pelvic radiotherapy.
- Active lower genital tract bleeding.
- Immunosuppressed state (e.g., HIV infection, status post organ transplantation).
- Failure to undergo the planned hysteroscopic evaluation and follow-up within 1 year after the initial assessment.
- Failed hysteroscopic procedure.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Study on Cervical Cytology DNA Methylation for Screening and Follow-up of Endometrial Lesions
The goal of this observational study is to evaluate the accuracy of a novel molecular test for screening and monitoring endometrial lesions in women at medium-to-high risk for endometrial cancer.
The main questions it aims to answer are:
Read more
- What is the sensitivity and specificity of the CISENDO test (a DNA methylation test on cervical cytology samples) for detecting histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer?
- How do DNA methylation levels change during the follow-up of endometrial lesions? Researchers will compare the results of the CISENDO test to the results from the standard diagnostic procedure (hysteroscopy with histology) to see if the molecular test can reliably identify high-risk lesions and track disease progression.
Participants will:
- Provide a residual liquid-based cervical cytology sample for the CISENDO test.
- Undergo a standard diagnostic hysteroscopy examination (with or without biopsy) for comparison.
- Some participants will return for follow-up visits at 6 and 12 months for repeat methylation testing and/or hysteroscopy to monitor their condition.
- Conditions
- Endometrial Neoplasms, DNA Methylation, Cervical Smears, Early Detection of Cancer, Endometrial Hyperplasia
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial Cancer Risk Cohort | This is a prospective, observational cohort of women at medium-to-high risk for endometrial cancer. All participants undergo baseline cervical cytology sampling for DNA methylation testing (CISENDO) and diagnostic hysteroscopy. Follow-up strategy is stratified based on initial methylation results and risk factors, with some receiving repeat methylation testing and/or hysteroscopy at 6 and 12 months, and others receiving methylation testing only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CISENDO Test
The proportion of participants with histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer who have a positive CISENDO test result at baseline.
Measured: Baseline (at the time of initial hysteroscopy)
Secondary outcomes (5)
Dynamic Change in DNA Methylation Level
The relative change in DNA methylation level (as measured by the CISENDO test) between baseline and follow-up visits (6 and 12 months) in participants undergoing surveillance.
Measured: From baseline to 12 months
Positive and Negative Predictive Values of CISENDO Test
The probability that participants with a positive test result truly have the disease (PPV), and the probability that those with a negative result truly do not have the disease (NPV), using histology as the gold standard.
Measured: Baseline
Diagnostic Accuracy (Area Under the ROC Curve)
The overall diagnostic performance of the CISENDO test, evaluated by the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC).
Measured: Baseline
Comparison of Screening Strategies
Comparison of diagnostic performance metrics (sensitivity, specificity, PPV, NPV) between the CISENDO test and traditional diagnostic pathways (e.g., ultrasound findings leading to hysteroscopy).
Measured: Baseline
Association of Methylation Level with Risk Stratification
The correlation between baseline DNA methylation levels and participants' clinical risk stratification according to Chinese consensus guidelines.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion31 Jul 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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The Third Xiangya Hospital of Central South University, Beijing Chuiyangliu Hospital, Beijing Sixth Hospital
- Responsible party
- Principal investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298707
- Sponsor's protocol ID
- K9518
- Other IDs
- ZS-2740
- Acronym
- EndoMethy-V
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on Cervical Cytology DNA Methylation for Screening and Follow-up of Endometrial Lesions
- ClinicalTrials.gov ID
- NCT07298707
- Acronym / sponsor ID
- EndoMethy-V / K9518
- Conditions
- Endometrial Neoplasms, DNA Methylation, Cervical Smears, Early Detection of Cancer, Endometrial Hyperplasia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The Third Xiangya Hospital of Central South University, Beijing Chuiyangliu Hospital, Beijing Sixth Hospital
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (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 the accuracy of a novel molecular test for screening and monitoring endometrial lesions in women at medium-to-high risk for endometrial cancer.
The main questions it aims to answer are:
- What is the sensitivity and specificity of the CISENDO test (a DNA methylation test on cervical cytology samples) for detecting histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer?
- How do DNA methylation levels change during the follow-up of endometrial lesions? Researchers will compare the results of the CISENDO test to the results from the standard diagnostic procedure (hysteroscopy with histology) to see if the molecular test can reliably identify high-risk lesions and track disease progression.
Participants will:
- Provide a residual liquid-based cervical cytology sample for the CISENDO test.
- Undergo a standard diagnostic hysteroscopy examination (with or without biopsy) for comparison.
- Some participants will return for follow-up visits at 6 and 12 months for repeat methylation testing and/or hysteroscopy to monitor their condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial Cancer Risk Cohort | – | –This is a prospective, observational cohort of women at medium-to-high risk for endometrial cancer. All participants undergo baseline cervical cytology sampling for DNA methylation testing (CISENDO) and diagnostic hysteroscopy. Follow-up strategy is stratified based on initial methylation results and risk factors, with some receiving repeat methylation testing and/or hysteroscopy at 6 and 12 months, and others receiving methylation testing only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This multicenter, prospective cohort study aims to enroll approximately 3,500 adult women in China who are at medium-to-high risk for endometrial cancer according to Chinese clinical consensus guidelines. The study population specifically includes two groups: 1) women who are scheduled for a diagnostic hysteroscopy due to these risk factors, and 2) women who are currently undergoing conservative treatment (such as progesterone therapy or endometrial ablation) for existing endometrial lesions and have not received chemotherapy. All participants must have an intact cervix and be willing to participate in follow-up assessments. Participants will be followed for up to 12 months, with the enrollment target set to observe at least 20 endpoint events (diagnosis of endometrial intraepithelial neoplasia or invasive cancer).
Key inclusion criteria (5 listed)
- Participants must be 18 years of age or older.
- Participants must possess medium-to-high risk factors for endometrial cancer as defined by Chinese consensus guidelines and are scheduled for hysteroscopic evaluation; OR are currently undergoing conservative treatment (e.g., progesterone therapy or endometrial ablation) for endometrial lesions, and have not received chemotherapy.
- Participants must be capable and willing to provide written informed consent.
- Participants must be willing to undergo at least one follow-up assessment within 1 year.
- Participants must have an intact cervix (a history of LEEP or conization is acceptable).
Key exclusion criteria (8 listed)
- Current treatment for any gynecologic malignancy other than endometrial cancer.
- Current or untreated cervical, vaginal, or vulvar intraepithelial neoplasia or carcinoma.
- History of total or subtotal hysterectomy, trachelectomy, radical trachelectomy, or pelvic radiotherapy.
- Active lower genital tract bleeding.
- Immunosuppressed state (e.g., HIV infection, status post organ transplantation).
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
Sensitivity of CISENDO Test
Time frame: Baseline (at the time of initial hysteroscopy)
The proportion of participants with histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer who have a positive CISENDO test result at baseline.
5 secondary outcomes
Dynamic Change in DNA Methylation Level
Time frame: From baseline to 12 months
Positive and Negative Predictive Values of CISENDO Test
Time frame: Baseline
Diagnostic Accuracy (Area Under the ROC Curve)
Time frame: Baseline
Comparison of Screening Strategies
Time frame: Baseline
Association of Methylation Level with Risk Stratification
Time frame: Baseline
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 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms and DNA Methylation, run by Peking Union Medical College Hospital.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Li Lei, Professor (+86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of CISENDO Test (time frame: Baseline (at the time of initial hysteroscopy)). 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 23 Dec 2025.