Clinical trial · Observational
Early Diagnosis of Oral Cancer by Detecting p16 Methylation
A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
NCT01695018CI-TRIAL-00015699completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mild Epithelial Dysplasia | Low Grade Intraepithelial Neoplasia | ALIAS | 0.90 |
| Moderate Epithelial Dysplasia | Grade II Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- p16 methylation positive
- description
- 48 patients with mild or moderate oral epithelial dysplasia containing methylated p16.
- label
- p16 methylation negative
- description
- 104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16.
Primary outcomes (1)
- measure
- Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation
- timeFrame
- frome 3 months to 63 months
- description
- 152 participants were p16 methylated informative. 29 participants were NOT informative because enough DNA was not extracted from their paraffin slides. Among these informative cases, oral specimens from 48 patients were p16 methylation positive and 104 patients were p16 methylation negative. The cancer rate in the p16 methylation positive patients during the followup period will be compared with that in the p16 methylation negative patients statistically.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria for mild to moderate grade OED * No local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips * Without the OCE treatment history by laser , radiation or chemical * Be able to Sign the informed consent Exclusion Criteria: * Histopathological diagnosis of oral lesions do not meet the epithelium of mild to moderate dysplasia diagnostic criteria; histological diagnosis of severe grade OED or malignant disease * Pregnancy or breast-feeding women * Serious heart, lung, liver , kidney and other systemic diseases * local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips * OED treatment history by LASER, radiotherapy, or chemotherapy * Tumor and psychiatric patients * Patients are unable to cooperate
References
Publications (0)
Data not yet available
No reference posted for this study.