Detection of Field Cancerization in the Clinically Normal Oral Mucosa of Cannabis and Cigarette Smokers (Ex-vivo Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- P53 expression as a surrogate marker for field cancerization
研究概览
简要总结
The aim of this study is to detect P53 expression in clinically normal oral mucosa of cigarette smokers, simultaneous cigarette and cannabis smokers and non-smokers as a surrogate marker for field cancerization.
详细描述
Roles and Responsibilities:
- Ali Abd El Wahed Abd El Fatah Kotb (A.K.) operator, data enterer, Assistant lecturer, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
- Professor Dr. Heba Dahmoush (H.D.) main supervisor, data monitoring,auditing professor, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
- Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Research Ethics Comittee (CREC)protocol reviewer in order to protect the right, safety, dignity and well-being of the participants, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
1- Intervention: A.K. will collect specimens from cigarette smokers and simultaneous cigarette and cannabis smokers. then the expression of p53 as a marker for field cancerization will be investigated in formaline fixed paraffine embedded specimens of mucosal biopsies obtained from the oral mucosa of both groups.
2-comparator: mucosal biopsies from non smokers will be investigated as a copmaratitive to smokers group.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years.
- •Simultaneous smokers to be included in the study must be frequent cigarette smokers (at least 10 cigarettes a day) for a period not less than 5 years plus frequent cannabis smoker (at least 3 times per week) for a period not less than 5 years.
排除标准
- •Exposure to other carcinogens.
- •un-clear smoking history.
- •medically compromised patients
结局指标
主要结局
P53 expression as a surrogate marker for field cancerization
时间窗: not less than 5 years
The areas containing the most uniformly stained tissues will be chosen for evaluation in area-area/area-percent measurments
次要结局
未报告次要终点
研究者
Ali Abdelwahed Kotb
assistant lecturer, oral and maxillofacial pathology- cairo university
Cairo University