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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445924
• Other study ID #: 2858/11/14
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: October 21, 2016
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

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

Locations

Country	Name	City	State
Egypt	Chest Department, Faculty of Medicine, Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Adel Salah Bediwy

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Keller A, Leidinger P, Borries A, Wendschlag A, Wucherpfennig F, Scheffler M, Huwer H, Lenhof HP, Meese E. miRNAs in lung cancer - studying complex fingerprints in patient's blood cells by microarray experiments. BMC Cancer. 2009 Oct 6;9:353. doi: 10.1186/1471-2407-9-353. — View Citation

Leidinger P, Keller A, Meese E. MicroRNAs - Important Molecules in Lung Cancer Research. Front Genet. 2012 Jan 23;2:104. doi: 10.3389/fgene.2011.00104. — View Citation

Tang D, Shen Y, Wang M, Yang R, Wang Z, Sui A, Jiao W, Wang Y. Identification of plasma microRNAs as novel noninvasive biomarkers for early detection of lung cancer. Eur J Cancer Prev. 2013 Nov;22(6):540-8. doi: 10.1097/CEJ.0b013e32835f3be9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray		one year	Yes