NCT07298707尚未招募不适用
A Multicenter Study on Cervical Cytology DNA Methylation for Screening and Follow-up of Endometrial Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,500
- 主要终点
- Sensitivity of CISENDO Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Sensitivity of CISENDO Test
时间窗: 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.
次要结局
- Dynamic Change in DNA Methylation Level(From baseline to 12 months)
- Positive and Negative Predictive Values of CISENDO Test(Baseline)
- Diagnostic Accuracy (Area Under the ROC Curve)(Baseline)
- Comparison of Screening Strategies(Baseline)
- Association of Methylation Level with Risk Stratification(Baseline)
研究者
Lei Li
Professor
Peking Union Medical College Hospital
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