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Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation

NCT06672341 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

  • Endometrial Cancer
  • Methylation
  • Cytology
  • Fertility Preservation
  • Screening Tool
  • Liquid Biopsy
  • Non-invasive

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Yulan Ren

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2025-11-01
Completion
2026-02-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672341 on ClinicalTrials.gov