Micro RNA Genetic Signature in NSCLC Egyptian Patients

NCT ID: NCT02445924

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-08-31

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group 1

ten non smoker volunteers

No interventions assigned to this group

Control group 2

ten smoker volunteers

No interventions assigned to this group

NSCLC patients

twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy, surgery or radiation therapy.

-

Exclusion Criteria

• 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.

• Diagnosis of asthma or COPD.
• Broncheiactasis.
• Upper/lower respiratory tract infection in the preceding 4 weeks.
• Active pulmonary tuberculosis
• Smoking in group I.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adel Salah Bediwy

OTHER

Sponsor Role: lead

Responsible Party

Adel Salah Bediwy

Assistant Professor of Chest Diseases, Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amgad A Farahat, MD

Role: STUDY_CHAIR

Chest Department, Faculty of Medicine, Tanta University

Ayman H Abd El-Zaher, MD

Role: PRINCIPAL_INVESTIGATOR

Chest Department, Faculty of Medicine, Tanta University

Said M Hammad, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pathology Department, Faculty of Medicine, Tanta University

Adel S Bediwy, MD

Role: PRINCIPAL_INVESTIGATOR

Chest Department, Faculty of Medicine, Tanta University

Ayman A Al Saka, MD

Role: PRINCIPAL_INVESTIGATOR

Pathology Department, Faculty of Medicine, Tanta University

Samar A Mansour, Master

Role: PRINCIPAL_INVESTIGATOR

Chest Department, Faculty of Medicine, Tanta University

Abdel-Aziz A Zidan, PHD

Role: PRINCIPAL_INVESTIGATOR

Director of Genomics and Proteomics Unit, Center of Excellence in Cancer Research, Tanta University

Locations

Chest Department, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 23462458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19807914 (View on PubMed)

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. eCollection 2011.

Reference Type: BACKGROUND

PMID: 22303398 (View on PubMed)

Other Identifiers

2858/11/14

Identifier Type: -

Identifier Source: org_study_id