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NCT05290428 Clinical Trial

DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

Cervical Cancer Clinical Trial

Official title:
The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05290428
Other study ID # METHY4
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 12, 2022
Est. completion date December 12, 2022

Study information
Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lie Li, M.D.
Phone 10-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 459
Est. completion date December 12, 2022
Est. primary completion date September 12, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DNA methylation testing
All cervical cytology samples will be tested for PAX1 and JAM3 methylation

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (3)
Lead Sponsor Collaborator
Peking Union Medical College Hospital Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of methylation testing Sensitivity of methylation testing of cervical cytology compared with histology One week
Primary Specificity of methylation testing Specificity of methylation testing of cervical cytology compared with histology One week
Secondary Positive predictive value of methylation testing Positive predictive value of methylation testing of cervical cytology compared with histology One week
Secondary Negative predictive value of methylation testing Negative predictive value of methylation testing of cervical cytology compared with histology One week
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