DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

• Conditions: Detection Accuracy; Cancer Screening; Cervical Cancer; Cervical Intraepithelial Neoplasia; DNA Methylation
• Interventions: Diagnostic Test: DNA methylation testing

• Registration Number: NCT05290428
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-12
• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-12
• Last Update Submitted: 2022-03-12
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-09-12
• Study Completion: 2022-12-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 459

Inclusion Criteria

• With uterine cervix intact
• Aged 18 years or older
• With accessible histological results of cervix
• Signed an approved informed consents
• With accessible cervical cytology before harvesting cervical histology

Exclusion Criteria

• Not meeting all of the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective part	DNA methylation testing	This part will enroll at least 120 cases in previously preserved samples.
Prospective part	DNA methylation testing	This part will enroll at least 339 cases.

Primary Outcome Measures

Name	Time	Method
Specificity of methylation testing	One week	Specificity of methylation testing of cervical cytology compared with histology
Sensitivity of methylation testing	One week	Sensitivity of methylation testing of cervical cytology compared with histology

Secondary Outcome Measures

Name	Time	Method
Negative predictive value of methylation testing	One week	Negative predictive value of methylation testing of cervical cytology compared with histology
Positive predictive value of methylation testing	One week	Positive predictive value of methylation testing of cervical cytology compared with histology

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China