DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening
The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
1 other identifier
observational
459
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2022
CompletedStudy Start
First participant enrolled
March 12, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2022
CompletedMarch 22, 2022
March 1, 2022
6 months
March 12, 2022
March 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of methylation testing
Sensitivity of methylation testing of cervical cytology compared with histology
One week
Specificity of methylation testing
Specificity of methylation testing of cervical cytology compared with histology
One week
Secondary Outcomes (2)
Positive predictive value of methylation testing
One week
Negative predictive value of methylation testing
One week
Study Arms (2)
Retrospective part
This part will enroll at least 120 cases in previously preserved samples.
Prospective part
This part will enroll at least 339 cases.
Interventions
All cervical cytology samples will be tested for PAX1 and JAM3 methylation
Eligibility Criteria
All participants will accept surgeries harvesting cervical histology.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lei Li
Beijing, Beijing Municipality, 100730, China
Biospecimen
Cervical cytology
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Li, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 12, 2022
First Posted
March 22, 2022
Study Start
March 12, 2022
Primary Completion
September 12, 2022
Study Completion
December 12, 2022
Last Updated
March 22, 2022
Record last verified: 2022-03