Micro RNA Genetic Signature in NSCLC Egyptian Patients

Adel Salah Bediwy

Status: Completed

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02445924

2858/11/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

40 participants in 3 patient groups

Control group 1

Description:

ten non smoker volunteers

Control group 2

Description:

ten smoker volunteers

NSCLC patients

Description:

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