- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02445924
Micro RNA Genetic Signature in NSCLC Egyptian Patients
Micro RNA Genetic Signature in Non-small Cell Lung Cancer Egyptian Patients
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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:
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.
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.
- Unexpected risks that appear during the courses of research will be cleared to the participants and the ethical committee on time.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Gharbia
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Tanta, Gharbia, Egitto, 31111
- Chest Department, Faculty of Medicine, Tanta University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
Inclusion Criteria:
- Inclusion criteria for patients:
Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy, surgery or radiation therapy.
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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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Control group 1
ten non smoker volunteers
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Control group 2
ten smoker volunteers
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NSCLC patients
twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray
Lasso di tempo: one year
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one year
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Abdel-Aziz A Zidan, PHD, Director of Genomics and Proteomics Unit, Center of Excellence in Cancer Research, Tanta University
- Cattedra di studio: Amgad A Farahat, MD, Chest Department, Faculty of Medicine, Tanta University
- Investigatore principale: Ayman H Abd El-Zaher, MD, Chest Department, Faculty of Medicine, Tanta University
- Investigatore principale: Said M Hammad, MD, Clinical Pathology Department, Faculty of Medicine, Tanta University
- Investigatore principale: Adel S Bediwy, MD, Chest Department, Faculty of Medicine, Tanta University
- Investigatore principale: Ayman A Al Saka, MD, Pathology Department, Faculty of Medicine, Tanta University
- Investigatore principale: Samar A Mansour, Master, Chest Department, Faculty of Medicine, Tanta University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2858/11/14
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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