Overview

This trial has been completed.

Condition non-small cell lung cancer
Sponsor Adel Salah Bediwy
Start date May 2015
End date January 2016
Trial size 40 participants
Trial identifier NCT02445924, 2858/11/14

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
ten non smoker volunteers
ten smoker volunteers
twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy

Primary Outcomes

Measure
Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Inclusion criteria for patients: Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy, surgery or radiation therapy. Exclusion Criteria: - 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.

Additional Information

Official title Micro RNA Genetic Signature in Non-small Cell Lung Cancer Egyptian Patients
Principal investigator Ayman H Abd El-Zaher, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Tanta University.