Cervical Cytology DNA Methylation for Endometrial Lesion Screening and Follow-up

NCT07298707NOT_YET_RECRUITINGOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

3500

Start Date

2026-01-10

Completion Date

2026-07-31

Study Type

OBSERVATIONAL

Official Title

A Multicenter Study on Cervical Cytology DNA Methylation for Screening and Follow-up of Endometrial Lesions

Conditions

Endometrial NeoplasmsDNA MethylationCervical SmearsEarly Detection of CancerEndometrial Hyperplasia

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

Time frame: Baseline (at the time of initial hysteroscopy)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: Baseline