Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia
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Purpose
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.
| Condition |
|---|
|
Oral Epithelial Dysplasia, Mild or Moderate Grade |
| Study Type: | Observational |
| 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 ]
- 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.
| Enrollment: | 93 |
| Study Start Date: | March 2005 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
p16-methylated
patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
|
|
p16-unmethylated
patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
|
Detailed Description:
- 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
101 patients with mild or moderate OED were selected from cases with oral leukoplakia, lichen planus, or chronic discoid erythematosus at Peking University School of Stomatology between 1995 and 2005. All of the patients with OED had been diagnosed pathologically by at least two senior pathologists using the criteria from '2005 WHO Classification System' (Gale et al, 2005). All cases involved primary lesions without any LASER, radiation therapy or chemotherapy. p16 methylation status of OED samples was analyzed with methylation-specific PCR combined with denatured high performance liquid chromatography (Sun et al, 2004). 93 eligible cases with p16-methylated or p16-unmethylated OED were enrolled into the cohort study.
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
Contacts and Locations| China | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Dajun Deng, Professor, Peking University School of Oncology |
| ClinicalTrials.gov Identifier: | NCT00835341 History of Changes |
| Other Study ID Numbers: | CPDHS-434 |
| Study First Received: | February 2, 2009 |
| Results First Received: | October 21, 2009 |
| Last Updated: | February 1, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Peking University:
|
oral epithelial dysplasia p16 methylation prognosis malignant transformation oral squamous cell carcinoma |
Additional relevant MeSH terms:
|
Hyperplasia Carcinoma in Situ Pathologic Processes Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013