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.

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Key information

Conditions

Oral Epithelial Dysplasia, Mild or Moderate Grade Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oral Medicine, Peking University School and Hospital of Stomatology

Beijing, 100081, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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.

Secondary outcomes

Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia

Time frame: from 3 months to 124 months

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Feb 3, 2009
Registry last updated: Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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