Clinical trial · Observational
Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation
A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation
NCT02967120CI-TRIAL-00029648unknownClinicalTrials.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 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Epithelial Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- p16 hydroxymethylation status
- description
- patients with p16 hydroxymethylation
- interventionNames
- Other: no intervention
Primary outcomes (1)
- measure
- Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 hydroxymethylation
- timeFrame
- from 3 months to 60 months
- description
- Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.
Secondary outcomes (1)
- measure
- Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 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 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 (3)
- BACKGROUNDLiu H, Liu XW, Dong G, Zhou J, Liu Y, Gao Y, Liu XY, Gu L, Sun Z, Deng D. P16 Methylation as an Early Predictor for Cancer Development From Oral Epithelial Dysplasia: A Double-blind Multicentre Prospective Study. EBioMedicine. 2015 Mar 23;2(5):432-7. doi: 10.1016/j.ebiom.2015.03.015. eCollection 2015 May. PMID 26137587
- BACKGROUNDCao J, Zhou J, Gao Y, Gu L, Meng H, Liu H, Deng D. Methylation of p16 CpG island associated with malignant progression of oral epithelial dysplasia: a prospective cohort study. Clin Cancer Res. 2009 Aug 15;15(16):5178-83. doi: 10.1158/1078-0432.CCR-09-0580. Epub 2009 Aug 11. PMID 19671846
- DERIVEDLiu H, Liu Z, Liu XW, Xu S, Wang L, Liu Y, Zhou J, Gu L, Gao Y, Liu XY, Shi H, Sun Z, Deng D. A similar effect of P16 hydroxymethylation and true-methylation on the prediction of malignant transformation of oral epithelial dysplasia: observation from a prospective study. BMC Cancer. 2018 Sep 24;18(1):918. doi: 10.1186/s12885-018-4787-6. PMID 30249192