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

Not yet recruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

November 4, 2024

Primary Completion Date

November 1, 2025

Study Completion Date

February 1, 2026

Conditions
Endometrial CancerMethylationCytologyFertility PreservationScreening ToolLiquid BiopsyNon-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.

All Listed Sponsors
lead

Yulan Ren

OTHER

NCT06672341 - Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation | Biotech Hunter | Biotech Hunter