DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

March 12, 2022 updated by: Lei Li, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

459

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All participants will accept surgeries harvesting cervical histology.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective part
This part will enroll at least 120 cases in previously preserved samples.
Diagnostic test: DNA methylation testing
All cervical cytology samples will be tested for PAX1 and JAM3 methylation
Prospective part
This part will enroll at least 339 cases.
Diagnostic test: DNA methylation testing
All cervical cytology samples will be tested for PAX1 and JAM3 methylation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of methylation testing
Time Frame: One week
Sensitivity of methylation testing of cervical cytology compared with histology
One week
Specificity of methylation testing
Time Frame: One week
Specificity of methylation testing of cervical cytology compared with histology
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value of methylation testing
Time Frame: One week
Positive predictive value of methylation testing of cervical cytology compared with histology
One week
Negative predictive value of methylation testing
Time Frame: One week
Negative predictive value of methylation testing of cervical cytology compared with histology
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2022

Primary Completion (ANTICIPATED)

September 12, 2022

Study Completion (ANTICIPATED)

December 12, 2022

Study Registration Dates

First Submitted

March 12, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (ACTUAL)

March 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METHY4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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