Cervical Smears, DNA Methylation, Early Detection of Cancer, Endometrial Hyperplasia, Endometrial Neoplasms
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Beijing Tiantan Hospital
The Third Xiangya Hospital of Central South University
Beijing Chuiyangliu Hospital
Beijing Sixth Hospital
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must be 18 years of age or older. 2. 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. 3. Participants must be capable and willing to provide written informed consent. 4. Participants must be willing to undergo at least one follow-up assessment within 1 year. 5. Participants must have an intact cervix (a history of LEEP or conization is acceptable).
Exclusion criteria
1. Current treatment for any gynecologic malignancy other than endometrial cancer. 2. Current or untreated cervical, vaginal, or vulvar intraepithelial neoplasia or carcinoma. 3. History of total or subtotal hysterectomy, trachelectomy, radical trachelectomy, or pelvic radiotherapy. 4. Active lower genital tract bleeding. 5. Immunosuppressed state (e.g., HIV infection, status post organ transplantation). 6. Failure to undergo the planned hysteroscopic evaluation and follow-up within 1 year after the initial assessment. 7. Failed hysteroscopic procedure. 8. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of CISENDO Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Change in DNA Methylation Level | From baseline to 12 months | 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. |
| Positive and Negative Predictive Values of CISENDO Test | Baseline | 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. |
| Diagnostic Accuracy (Area Under the ROC Curve) | Baseline | The overall diagnostic performance of the CISENDO test, evaluated by the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC). |
| Comparison of Screening Strategies | Baseline | Comparison of diagnostic performance metrics (sensitivity, specificity, PPV, NPV) between the CISENDO test and traditional diagnostic pathways (e.g., ultrasound findings leading to hysteroscopy). |
| Association of Methylation Level with Risk Stratification | Baseline | The correlation between baseline DNA methylation levels and participants' clinical risk stratification according to Chinese consensus guidelines. |
Contacts
Primary ContactLi Lei, Professor
Outcome results
None listed