Clinical trial · Observational
Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia
A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation
- 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)
Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. Biomarker is not available for detection of malignant potential of OED till now. p16 is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG island in early stage of carcinogenesis. The present cohort study is to investigate whether p16 methylation is correlated with malignant transformation of OED.
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, Mild or Moderate Grade | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- p16-methylated
- description
- patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
- label
- p16-unmethylated
- description
- patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
Primary outcomes (1)
- measure
- The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia
- timeFrame
- from 3 months to 124 months
- description
- The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * histological diagnosis of mild or moderate grade OED; and * enough amount of tissue sample from OED lesion for genomic DNA extraction; and * available of methylation status of p16 CpG island in the extracted DNA sample. Exclusion Criteria: * histological diagnosis of severe grade OED or malignant disease; or * amount of tissue sample is not enough for preparation of genomic DNA (20ng); or * quality of the prepared DNA is not good enough for detection of p16 methylation; or * OED treatment history by LASER, radiotherapy, or chemotherapy
References
Publications (3)
- BACKGROUNDGale N, Westra W, Pilch BZ, et al. Epithelial precursors lesions. In: Barnes L, Eveson JW, Reichart P, et al. eds. World Health Organization Classification of Tumors: Pathology and Genetics of Head and Neck Tumors. IARC Press, Lyon (France); 2005: 177-179.
- BACKGROUNDSun Y, Deng D, You WC, Bai H, Zhang L, Zhou J, Shen L, Ma JL, Xie YQ, Li JY. Methylation of p16 CpG islands associated with malignant transformation of gastric dysplasia in a population-based study. Clin Cancer Res. 2004 Aug 1;10(15):5087-93. doi: 10.1158/1078-0432.CCR-03-0622. PMID 15297411
- RESULTCao 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