Micro RNA Genetic Signature in NSCLC Egyptian Patients
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      The patients and control groups will be subjected to the following:

        -  Complete history taking and complete general examination.

        -  Complete chest examination.

        -  Radiological assessment including chest x ray (posteroanterior and lateral view).

        -  Computed tomography (CT) chest for all patients in group III and when needed in group I
           and II.

        -  Laboratory investigations:

             -  Complete blood picture

             -  Fasting and post parandial blood sugar level

             -  liver function tests

             -  kidney function tests (urea and creatinine).

             -  Prothrombine time and activity.

             -  Zeil-Neelsen staining of sputum.

             -  Tumour markers including α Fetoprotein, Carcino Embryonic antigen (CEA), CA19-9, CA
                125, CA15-3 and others.

        -  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.

        -  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.

        -  Bronchoalveolar lavage will be performed with isolation of total RNA from it. RNA
           profiles will be assessed using Microarray.

      Ethical considerations:

        1. Informed consent will be taken from all subject's and include:

           A. The aim of research. B. All data are confidential. C. All data will be used in
           research only.

        2. For patient's privacy:

           A. There will be a code number for each patient in special folder. B. The results of
           research will be used in scientific publishing only.

        3. Unexpected risks that appear during the courses of research will be cleared to the
           participants and the ethical committee on time.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      blood, bronchial lavage, bronchial biopsies
    
Keywords: genetic signature; non-small cell lung cancer; micro RNA