Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia
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.
Oral Epithelial Dysplasia, Mild or Moderate Grade
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation|
- The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia [ Time Frame: from 3 months to 124 months ] [ Designated as safety issue: No ]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.
- Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia [ Time Frame: from 3 months to 124 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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.
|Study Start Date:||March 2005|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835341
|Department of Oral Medicine, Peking University School and Hospital of Stomatology|
|Beijing, China, 100081|
|Study Director:||Dajun Deng, MD||Beijing Cancer Hospital/ Institue, Peking University School of Oncology|
|Principal Investigator:||Hongwei Liu, MD, PhD||Peking University School of Stomatology|