Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Screening | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Detection Accuracy | — | UNRESOLVED | — |
| DNA Methylation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA methylation testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective part
- description
- This part will enroll at least 120 cases in previously preserved samples.
- interventionNames
- Diagnostic Test: DNA methylation testing
- label
- Prospective part
- description
- This part will enroll at least 339 cases.
- interventionNames
- Diagnostic Test: DNA methylation testing
Primary outcomes (2)
- measure
- Sensitivity of methylation testing
- timeFrame
- One week
- description
- Sensitivity of methylation testing of cervical cytology compared with histology
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available