Micro RNA Genetic Signature in NSCLC Egyptian Patients

Non-small Cell Lung Cancer Clinical Trial

Official title: Micro RNA Genetic Signature in Non-small Cell Lung Cancer Egyptian Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT02445924
• Study type: Observational
• Source: Tanta University
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Completion date: August 2016