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Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation
Sponsor: Yulan Ren
Summary
The current study aims to assess high-risk patients using both liquid-based cytology and cervical methylation testing. The results will be compared with the traditional hysteroscopic pathological findings to determine the sensitivity and specificity of these methods for early detection of endometrial cancer, thereby evaluating their potential application in early screening. Primary Objectives： 1. To evaluate the sensitivity, specificity, and accuracy of endometrial cytology for screening endometrial cancer. 2. To assess the sensitivity, specificity, and accuracy of methylation testing for screening endometrial cancer. 3. To perform further molecular testing on tissue samples obtained from endometrial cytology and cervical methylation tests, aiming to explore early screening-sensitive indicators. Secondary Objectives： 1. To determine the value of endometrial cytology in evaluating the efficacy of fertility-sparing treatments for endometrial cancer. 2. To assess the value of methylation testing in evaluating the efficacy of fertility-sparing treatments for endometrial cancer.
Official title: A Prospective, Open, Observational Clinical Study on Endometrial Cytology and Cervical Methylation Testing for Screening and Evaluating Fertility-Sparing Treatment in Endometrial Cancer
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2024-11-04
Completion Date
2026-02-01
Last Updated
2024-11-05
Healthy Volunteers
No
Conditions
Interventions
Endometrial Cytology Testing
Endometrial Cytology Examination Liquid-based endometrial cytology is an emerging minimally invasive screening technique. This method involves collecting endometrial cells and tissues from the uterus and its downstream anatomical structures. The samples are preserved and analyzed using either liquid-based cytology techniques or tissue smear methods to reach a pathological diagnosis. Compared to invasive procedures such as fractional curettage, liquid-based cytology offers advantages in the screening of endometrial cancer, including being minimally invasive, convenient, and low-risk.
Cervical Methylation Testing
Cervical Cell Methylation Testing Cervical cell methylation testing is another promising method for methylation-based screening of endometrial cancer. This approach targets specific genes that undergo methylation in the early stages of endometrial cancer. The combined methylation analysis of four genes (CD01, BHLHE22, ACTB, and SEPTIN9) uses menstrual blood or vaginal secretions as samples, offering advantages such as safety, non-invasiveness, and self-collection. This method has shown high sensitivity and specificity for the early detection of endometrial cancer. Ongoing research suggests that the sensitivity and specificity of cervical cell methylation testing can reach 93.2% and 96%, respectively, although this data is yet to be published.