Micro RNA Genetic Signature in Non-small Cell Lung Cancer Egyptian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray
研究概览
简要总结
This study will be carried out on 40 subjects at Chest department Tanta university hospital
The subjects will be classified into three groups:
- Group I: will include ten non smoker volunteers (control group I).
- GroupII: will include ten smoker volunteers (control groupII).
- Group III: will include twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy.
详细描述
The patients and control groups will be subjected to the following:
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Complete history taking and complete general examination.
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Complete chest examination.
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Radiological assessment including chest x ray (posteroanterior and lateral view).
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Computed tomography (CT) chest for all patients in group III and when needed in group I and II.
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Laboratory investigations:
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Complete blood picture
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Fasting and post parandial blood sugar level
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liver function tests
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kidney function tests (urea and creatinine).
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Prothrombine time and activity.
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Zeil-Neelsen staining of sputum.
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Tumour markers including α Fetoprotein, Carcino Embryonic antigen (CEA), CA19-9, CA 125, CA15-3 and others.
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Venous blood samples will be collected from peripheral blood (5 ml) under complete aseptic technique. Serum samples will be obtained by centrifugation. Isolation of total RNA from serum pools will be performed. RNA profiles and quantification will be assessed using Microarray.
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Lung biopsy either transbronchial via bronchoscopy or peripherally via ultrasound , CT guided, thoracoscopy or open lung biopsy will be performed with isolation of total RNA from lung tissue biopsy. RNA profiles and quantification will be assessed using Microarray.
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Bronchoalveolar lavage will be performed with isolation of total RNA from it. RNA profiles will be assessed using Microarray.
Ethical considerations:
- Informed consent will be taken from all subject's and include:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for patients:
- •Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy, surgery or radiation therapy.
排除标准
- •Exclusion criteria for patients:
- •Diagnosis of asthma or COPD.
- •Broncheiactasis.
- •upper/lower respiratory tract infection in the preceding 4 weeks.
- •Active pulmonary tuberculosis.
- •Associated cancer beside lung cancer.
- •Patients who received chemotherapy, surgery or radiation therapy previous to the sample collection.
- •Exclusion criteria for control subjects:
- •Diagnosis of asthma or COPD.
- •Broncheiactasis.
- •Upper/lower respiratory tract infection in the preceding 4 weeks.
- •Active pulmonary tuberculosis
- •Smoking in group I.
结局指标
主要结局
Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray
时间窗: one year
次要结局
未报告次要终点
研究者
Adel Salah Bediwy
Assistant Professor of Chest Diseases, Faculty of Medicine
Tanta University