Oral Epithelial Dysplasia, Mild or Moderate Grade Clinical Trial
Official title:
A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation
| Verified date | May 2015 |
| Source | Peking University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Oral Medicine, Peking University School and Hospital of Stomatology | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University |
China,
Cao 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-09-058 — View Citation
Gale 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.
Sun 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia | 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. | from 3 months to 124 months | No |
| Secondary | Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia | from 3 months to 124 months | No |