Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Hyperplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Oral Squamous Cell Carcinoma

patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.

patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.

Dajun Deng, MD

Hongwei Liu, MD, PhD

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.

* Background: Identification of malignant potential of oral epithelial dysplasia (OED) is virtually impossible on histopathological grounds alone. Inactivation of p16 gene by CpG methylation is an early frequent event during oral carcinogenesis. To investigate the predictive value of p16 methylation on malignant potential in OED, we carried out the prospective cohort study.
* Methods: 101 patients with histologically confirmed mild or moderate OED were included in the present study. Baseline information of p16 methylation status of the OED lesions from 93 cases was obtained by methylation-specific PCR. Progression of the OEDs lesions was examined in 78 cases histologically during the 45.8 months double-blind followup survey (78/93). The association between p16 methylation and progression of OED was analyzed with SPSS13.0 software. All P-values were two-sided.

Tissue specimen are collected from outpatients and inpatients with oral leukoplakia by biopsy or surgical resection, fixed in neutral buffered formalin, and embedded in paraffin. Genomic DNA is extracted from tissue sections.

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

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.

Peking University

Professor and Department Director

All participants only got regular examinations during the followup period. No extra treatment was administrated.

p16-methylated

p16-unmethylated

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

China

Region of Enrollment

Department of Etiology

The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia

Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia	NCT00835341	Oral Epithelial...		-	Peking University
Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia	NCT00835341	Oral Epithelial...		-	Peking University

Spots Global Cancer Trial Database for oral epithelial dysplasia, mild or moderate grade