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DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05290428
Collaborator
Zhejiang Provincial People's Hospital (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
459
Enrollment
1
Location
9
Anticipated Duration (Months)
50.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: DNA methylation testing

Study Design

Study Type:
Observational
Anticipated Enrollment :
459 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
Actual Study Start Date :
Mar 12, 2022
Anticipated Primary Completion Date :
Sep 12, 2022
Anticipated Study Completion Date :
Dec 12, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of methylation testing [One week]

    Sensitivity of methylation testing of cervical cytology compared with histology

  2. Specificity of methylation testing [One week]

    Specificity of methylation testing of cervical cytology compared with histology

Secondary Outcome Measures

  1. Positive predictive value of methylation testing [One week]

    Positive predictive value of methylation testing of cervical cytology compared with histology

  2. Negative predictive value of methylation testing [One week]

    Negative predictive value of methylation testing of cervical cytology compared with histology

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital
  • Zhejiang Provincial People's Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05290428
Other Study ID Numbers:
  • METHY4
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Mar 22, 2022