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Sponsored by: |
Peking University |
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Information provided by: | Peking University |
ClinicalTrials.gov Identifier: | NCT00835341 |
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 |
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Oral Epithelial Dysplasia, Mild or Moderate Grade |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation |
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 |
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p16-methylated
patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
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p16-unmethylated
patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
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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.
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:
Exclusion Criteria:
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 |
Responsible Party: | Peking University School of Oncology ( Dajun Deng, Professor ) |
Study ID Numbers: | CPDHS-434 |
Study First Received: | February 2, 2009 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00835341 History of Changes |
Health Authority: | China: Ethics Committee |
malignant transformation oral epithelial dysplasia oral squamous cell carcinoma p16 methylation prognosis |
Carcinoma in Situ Epidermoid Carcinoma Squamous Cell Carcinoma Carcinoma, Squamous Cell |
Oral Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Carcinoma in Situ Neoplasms, Glandular and Epithelial Carcinoma |