Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study
Background: Induced sputum (IS) is a noninvasive methodology for evaluating airway inflammation in a large number of pulmonary diseases, i.e, Asthma, Chronic obstructive pulmonary disease and Interstitial Lung Diseases. Several studies have defined normal values and cut-off points for this technique based on cellular components of IS, such as percentages of eosinophils, neutrophils, macrophages and CD4/CD8 ratio of T cell lymphocytes. However, normal values and cut-off points for lymphocyte percentages indicative of pathology have not yet been established or validated. This component of IS has considerable clinical value. Similar to other constituents of IS, it can provide biological insights into the pathogenesis of respiratory disorders and contribute to establishing the diagnosis and guiding treatment management of a variety of airway diseases.
The purposes of this study are to define normal values and cut-off points of lymphocytes in IS among individuals with respiratory disorders and healthy volunteers, and to verify the current reference values of the percentage of eosinophils, neutrophils and CD4/CD8 ratio in IS.
Methods: A Cross Sectional study which includes a database on up to 900 patients who participated in various studies conducted in the Pulmonary Laboratory of Tel Aviv Sourasky Medical Center between 2005 to 2012 will be established. The study population will include patients diagnosed as having various pulmonary diseases and a group of healthy volunteers who will serve as controls. The cut-off for normal values of lymphocyte, eosinophil and neutrophil percentages and CD4/CD8 ratio in IS will be defined by using ROC curves and evaluating sensitivity and specificity. The comparison of the different values to those in the literature will be done by using the Spearman rank correlation.
The results of this study will provide supplementary information on lymphocyte counts in IS for identifying and treating various respiratory diseases.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- patients suffering from pulmonary symptoms or diseases
- patients with occupational or environmental exposure
Exclusion Criteria:
- indefinite spirometry tests
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Healthy non exposed
Healthy patients with no pulmonary symptoms that were not exposed to occupational or environmental exposure
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Healthy exposed
Healthy patients with no pulmonary symptoms that were exposed to occupational or environmental exposure
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Non-healthy exposed
Patients with pulmonary symptoms or diseases that were exposed to occupational or environmental exposure
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Non-healthy non-exposed
Patients with pulmonary symptoms or diseases that were not exposed to occupational or environmental exposure
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Healthy patients vs. non-healthy patients
Periodo de tiempo: 1 year
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Healthy patients are those who did not suffer from major respiratory symptoms, were not diagnosed with any pulmonary diseases and had normal pulmonary function tests (i.e, FEV1>80%, FEV1/FVC ratio>75%). Non-healthy patients are those who suffered from respiratory symptoms, were diagnosed with a pulmonary disease or had abnormal pulmonary function tests (i.e, FEV1<80%, FEV1/FVC ratio<75%). |
1 year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Eosinophil percentage out of all White blood cells in Sputum sample
Periodo de tiempo: Up to 1 day from sputum induction
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Up to 1 day from sputum induction
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Neutrophil percentage out of all White blood cells in Sputum sample
Periodo de tiempo: Up to 1 day from sputum induction
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Up to 1 day from sputum induction
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T cell Lymphocyte cluster of differentiation 4 / cluster of differentiation 8 (CD4/CD8) ratio in Sputum sample
Periodo de tiempo: Up to 1 day from sputum induction
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Up to 1 day from sputum induction
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Lymphocyte percentage out of all White blood cells in Sputum sample
Periodo de tiempo: Up to 1 day from sputum induction
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Up to 1 day from sputum induction
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shmuel Kivity, Professor, Tel-Aviv Sourasky Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Pin I, Gibson PG, Kolendowicz R, Girgis-Gabardo A, Denburg JA, Hargreave FE, Dolovich J. Use of induced sputum cell counts to investigate airway inflammation in asthma. Thorax. 1992 Jan;47(1):25-9. doi: 10.1136/thx.47.1.25.
- Balbi B, Pignatti P, Corradi M, Baiardi P, Bianchi L, Brunetti G, Radaeli A, Moscato G, Mutti A, Spanevello A, Malerba M. Bronchoalveolar lavage, sputum and exhaled clinically relevant inflammatory markers: values in healthy adults. Eur Respir J. 2007 Oct;30(4):769-81. doi: 10.1183/09031936.00112306.
- Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A, Lazarov E, Fireman E. The use of induced sputum in the assessment of pulmonary involvement in Crohn's disease. Am J Gastroenterol. 2000 Mar;95(3):730-4. doi: 10.1111/j.1572-0241.2000.01843.x.
- Fireman E, Topilsky I, Greif J, Lerman Y, Schwarz Y, Man A, Topilsky M. Induced sputum compared to bronchoalveolar lavage for evaluating patients with sarcoidosis and non-granulomatous interstitial lung disease. Respir Med. 1999 Nov;93(11):827-34. doi: 10.1016/s0954-6111(99)90269-x.
- Fireman E, Boikaner T, Priel IE. Combined CD4/CD8 ratio in induced sputum and pulmonary function testing for non-invasive identification of sarcoidosis. Transl Res. 2006 Aug;148(2):87-95. doi: 10.1016/j.trsl.2006.03.005.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TASMC-14-SK-0629-13-CTIL
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