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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia | from 3 months to 124 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dajun Deng, MD | Beijing Cancer Hospital/ Institue, Peking University School of Oncology | Study Director |
| Hongwei Liu, MD, PhD | Peking University School of Stomatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral Medicine, Peking University School and Hospital of Stomatology | Beijing | 100081 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 15297411 | Background | 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. doi: 10.1158/1078-0432.CCR-03-0622. | |
| 19671846 |
| Label | URL |
|---|---|
| Beijing Cancer Hospital/ Institute, Peking University School of Oncology | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | p16-methylated | patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island. |
| FG001 | p16-unmethylated | patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | p16-methylated | patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island. |
| BG001 | p16-unmethylated | patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | from 3 months to 124 months |
|
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All participants only got regular examinations during the followup period. No extra treatment was administrated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | p16-methylated | patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department of Etiology | Peking University School of Oncology | +8610-88196752 | dengdajun@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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.
| Result |
| 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-09-0580. Epub 2009 Aug 11. |
| Peking University School of Stomatology | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | p16-unmethylated | patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island. |
|
|
| Secondary | Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia | Not Posted | from 3 months to 124 months |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | p16-unmethylated | patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island. | 0 | 58 | 0 | 58 |
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |