Clinical trial · Observational
DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening
The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial 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 NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for endometrial screening. Four 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 CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 7150 patients.
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 | Endometrial Neoplasm | PROBABILISTIC | 0.70 |
| Cervical Cytology | — | UNRESOLVED | — |
| DNA Methylation | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Testing Accuracy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA methylation testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Sensitivity of methylation testing
- timeFrame
- One week
- description
- Sensitivity of methylation testing of cervical cytology compared with histology
- measure
- Specificity of methylation testing
- timeFrame
- One week
- description
- Specificity of methylation testing of cervical cytology compared with histology
Secondary outcomes (2)
- measure
- Positive predictive value of methylation testing
- timeFrame
- One week
- description
- Positive predictive value 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 uerine and uterine cervix intact * Aged 18 years or older * With accessible histological results of endometrium * Signed an approved informed consents * With accessible cervical cytology before harvesting endometrial histology Exclusion Criteria: * Not meeting all of the inclusion criteria
References
Publications (0)
Data not yet available