N/A
Completed N=93
Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia
Oral Epithelial Dysplasia, Mild or Moderate Grade
Source: ClinicalTrials.gov NCT00835341 ↗
Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia — 32; 46 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia |
32; 46 | — |
| SECONDARY Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00835341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.