Morphological Parameters of Blood Cell's Activation in Characterization and Prognosis in a COPD Patients Cohort
NCT ID: NCT04923360
Last Updated: 2021-06-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-01-01
Study Completion Date
2022-06-01
Brief Summary
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Though exacerbations in the COPD (Chronic Pulmonary Obstructive Disease) and specially the most severe cases (hospitalizations) are currently a fundamental outcome in the COPD due to its clinical and economic significance, there are many unanswered questions still today such as the very definition of exacerbation itself.
Research parameters like the CPD (Cell Population Data) are added to the basic blood count. The CPD of the XN analyzers (Sysmex Corporation, Kobe, Japan) provide quantitative information of the morphological and functional characteristics of the leukocytes: their volume, content of nucleic acids and structure of the cytoplasm. The CPD are numerical data which represent the morphology which characterizes the neutrophils, lymphocytes, monocytes, eosinophils and platelets classifying them as per their volume and shape, granularity and their content of nucleic acids. The approach is that such cheap and accessible technique can provide relevant information in the area of COPD exacerbations.
Therefore, this study proposes several objectives:
1. Establish the CPD values for each phenotype of COPD (both for those already established in the Spanish guide of COPD and in the potential phenotypes which may be established in this study based on the CPDs themselves).
2. Identify which, among the CPDs, are more relevant in relation to cellular activation (neutrophils, lymphocytes, eosinophils and platelets) both in the stage of clinical stability and during the severe exacerbation.
3. Establish different phenotypes of COPD (in stable phase) according to the CPD values.
4. Determine the existence of an association between the level of activation of these cells in stability phase of the COPD and the risk of exacerbation; establish the optimum cutoff points.
The study will include 500 patients with different levels of COPD in the OSI-Barrualde and OSI-Bilbao. Several clinical measurements will be carried out for their characterization. CPD measurements will be made both in clinical stability phase or during exacerbations.
Research parameters like the CPD (Cell Population Data) are added to the basic blood count. The CPD of the XN analyzers (Sysmex Corporation, Kobe, Japan) provide quantitative information of the morphological and functional characteristics of the leukocytes: their volume, content of nucleic acids and structure of the cytoplasm. The CPD are numerical data which represent the morphology which characterizes the neutrophils, lymphocytes, monocytes, eosinophils and platelets classifying them as per their volume and shape, granularity and their content of nucleic acids. The approach is that such cheap and accessible technique can provide relevant information in the area of COPD exacerbations.
Therefore, this study proposes several objectives:
1. Establish the CPD values for each phenotype of COPD (both for those already established in the Spanish guide of COPD and in the potential phenotypes which may be established in this study based on the CPDs themselves).
2. Identify which, among the CPDs, are more relevant in relation to cellular activation (neutrophils, lymphocytes, eosinophils and platelets) both in the stage of clinical stability and during the severe exacerbation.
3. Establish different phenotypes of COPD (in stable phase) according to the CPD values.
4. Determine the existence of an association between the level of activation of these cells in stability phase of the COPD and the risk of exacerbation; establish the optimum cutoff points.
The study will include 500 patients with different levels of COPD in the OSI-Barrualde and OSI-Bilbao. Several clinical measurements will be carried out for their characterization. CPD measurements will be made both in clinical stability phase or during exacerbations.
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Detailed Description
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One of the most analyzed outcomes in COPD (Chronic Pulmonary Obstructive Disease) are the exacerbations, specially the severe ones. There are two challenges in relation to severe exacerbations: one related to the high use of sanitary resources and costs; and the second one, related to the worsening of the pulmonary function and the quality of life.
Nowadays in the Spanish COPD guideline called GESEPOC (Guía Española de la Enfermedad Pulmonar Obstructiva Crónica), there is a COPD "exacerbator" phenotype. However, there are some limitations round the COPD exacerbation, like its definition or its predictors. In other words, there are no indicators that can help the investigators to define more precisely an exacerbation or the COPD exacerbator profile.
COPD is a chronic disease with low intensity, systemic and chronic inflammation. The matter is that it is not established which indicators the investigators have to use to determinate it. There are some indicators like C reactive protein, TNF-alpha, IL-6 (Interleukin 6), microalbumins and adiponectin; and there are also prognostic scores based on them. However, they cannot help the investigators to establish COPD phenotypes of patients that can suffer an exacerbation. The investigators neither have indicators in stable phase that say them the risk of an exacerbation. Moreover, it is said that there are different types of exacerbations and even it has been established indicators of these exacerbation phenotypes. However, nowadays it cannot be translated into daily clinical practice. If investigators would be able to do it, they could advance in the knowledge of the exacerbations and they could establish precision treatments.
The blood count is one of the most required laboratory test in clinical practice. It is cost-effective because of its low price and the huge quantity of information it brings. After adapting the flow cytometry in hematologic modern analyzers, a more detailed study of cells can be done. Moreover, morphological changes can be detected in response to different stimulus, like infections or the ones that are caused by inflammatory reactions.
In this project, CPD ("Cellular Popular Data") is added to the basis blood count. They are parameters that are under investigation nowadays. The CPD of the XN analyzers (Sysmex Corporation, Kobe, Japan) give quantitative information about morphological and functional characteristics of leukocytes: their volume, the quantity of nucleic acid they contain and the structure of the cytoplasm. The CPD are numeric data that represent the morphology of the neutrophils, lymphocytes, monocytes and eosinophils, and they classify them by their volume, form, granularity and nucleic acid content. The same technology allows to the analyzer to classify the platelets by their morphology, what is related to its thrombogenic activity.
The composition of the membrane of the activated cells is different from the one of cells that are at rest, because of the expression of the receptors and the surface signaling molecules, in response to the activation. This membrane is more sensitive to the reagents of the analyzer, and more quantity of fluorescent colorant can enter in the activated cell and link to the cytoplasmic organelles and nucleic acids. The optic signals are different, what allows to distinguish morphological changes, and they are directly related to the cell functionality.
The activated neutrophils and monocytes have more "deformability", mobility and more capacity to adhesion, granulation and liberation of cytokines.
CPD values reflect morphological and functional transformation of these activated cells, and they give us very important information of the state of the cell and the state of the patient at the moment the sample is taken.
In addition, CPD support the differentiation between viral and bacterial infections or between acute and chronic infections, but also they say if there is an inflammatory condition without infection, with better diagnostic performance than conventional parameters, like total leukocytes, neutrophiles percentage and C reactive protein, that traditionally are used like acute infection markers.
Currently available literature speaks about the utility of CPD in the diagnosis, but there is no data about their possible prognostic value.
Respect from blood cells, previous COPD studies showed the relation between neutrophils/lymphocytes and platelets/lymphocytes as prognostic factors during severe exacerbations in COPD. Nowadays, it is emphasized the importance of eosinophils in COPD like predictor of exacerbation, like exacerbation severity marker and like response marker to the treatment in stable and in the exacerbation phase. It is thought that in this study the prognostic capacity of these new approaches can be better, becauseit is included the grade of activation of these cells like key parameter. This is a novel approach in the COPD field.
On the other hand, other inflammatory biomarkers (TNF-alpha, IL-6…) are expensive and less accessible in the daily clinical practice, while the evaluation of these new biomarkers of leukocytes are cheaper and more available in routine clinical practice by the blood count.
These new biomarkers could help the investigators confirming the inflammatory response and recognizing patients that could exacerbate. They also could determine the kind of their exacerbation and their prognosis.
Nowadays in the Spanish COPD guideline called GESEPOC (Guía Española de la Enfermedad Pulmonar Obstructiva Crónica), there is a COPD "exacerbator" phenotype. However, there are some limitations round the COPD exacerbation, like its definition or its predictors. In other words, there are no indicators that can help the investigators to define more precisely an exacerbation or the COPD exacerbator profile.
COPD is a chronic disease with low intensity, systemic and chronic inflammation. The matter is that it is not established which indicators the investigators have to use to determinate it. There are some indicators like C reactive protein, TNF-alpha, IL-6 (Interleukin 6), microalbumins and adiponectin; and there are also prognostic scores based on them. However, they cannot help the investigators to establish COPD phenotypes of patients that can suffer an exacerbation. The investigators neither have indicators in stable phase that say them the risk of an exacerbation. Moreover, it is said that there are different types of exacerbations and even it has been established indicators of these exacerbation phenotypes. However, nowadays it cannot be translated into daily clinical practice. If investigators would be able to do it, they could advance in the knowledge of the exacerbations and they could establish precision treatments.
The blood count is one of the most required laboratory test in clinical practice. It is cost-effective because of its low price and the huge quantity of information it brings. After adapting the flow cytometry in hematologic modern analyzers, a more detailed study of cells can be done. Moreover, morphological changes can be detected in response to different stimulus, like infections or the ones that are caused by inflammatory reactions.
In this project, CPD ("Cellular Popular Data") is added to the basis blood count. They are parameters that are under investigation nowadays. The CPD of the XN analyzers (Sysmex Corporation, Kobe, Japan) give quantitative information about morphological and functional characteristics of leukocytes: their volume, the quantity of nucleic acid they contain and the structure of the cytoplasm. The CPD are numeric data that represent the morphology of the neutrophils, lymphocytes, monocytes and eosinophils, and they classify them by their volume, form, granularity and nucleic acid content. The same technology allows to the analyzer to classify the platelets by their morphology, what is related to its thrombogenic activity.
The composition of the membrane of the activated cells is different from the one of cells that are at rest, because of the expression of the receptors and the surface signaling molecules, in response to the activation. This membrane is more sensitive to the reagents of the analyzer, and more quantity of fluorescent colorant can enter in the activated cell and link to the cytoplasmic organelles and nucleic acids. The optic signals are different, what allows to distinguish morphological changes, and they are directly related to the cell functionality.
The activated neutrophils and monocytes have more "deformability", mobility and more capacity to adhesion, granulation and liberation of cytokines.
CPD values reflect morphological and functional transformation of these activated cells, and they give us very important information of the state of the cell and the state of the patient at the moment the sample is taken.
In addition, CPD support the differentiation between viral and bacterial infections or between acute and chronic infections, but also they say if there is an inflammatory condition without infection, with better diagnostic performance than conventional parameters, like total leukocytes, neutrophiles percentage and C reactive protein, that traditionally are used like acute infection markers.
Currently available literature speaks about the utility of CPD in the diagnosis, but there is no data about their possible prognostic value.
Respect from blood cells, previous COPD studies showed the relation between neutrophils/lymphocytes and platelets/lymphocytes as prognostic factors during severe exacerbations in COPD. Nowadays, it is emphasized the importance of eosinophils in COPD like predictor of exacerbation, like exacerbation severity marker and like response marker to the treatment in stable and in the exacerbation phase. It is thought that in this study the prognostic capacity of these new approaches can be better, becauseit is included the grade of activation of these cells like key parameter. This is a novel approach in the COPD field.
On the other hand, other inflammatory biomarkers (TNF-alpha, IL-6…) are expensive and less accessible in the daily clinical practice, while the evaluation of these new biomarkers of leukocytes are cheaper and more available in routine clinical practice by the blood count.
These new biomarkers could help the investigators confirming the inflammatory response and recognizing patients that could exacerbate. They also could determine the kind of their exacerbation and their prognosis.
Conditions
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COPD
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* COPD diagnosis following American Thoracic Association (Am Rev Respir Dis 1987;136:225-244), FEV1/FVC \< 70% (FEV1: forced expiratory volume in one second, FVC: forced vital capacity) post-bronchodilator. Acceptation to participate in the study by the informed consent.
Exclusion Criteria
* Concomitant diseases that could interfere in the realization of the measures in the study (dementia, severe psychiatric disease, invalidating neurological diseases, important deafness, active neoplasms); patients with asthma as main diagnostic; patients with bronchiectasis as main disease or with extensive sequels of pulmonary tuberculosis; patients that in the beginning seem to be unable to follow the procedures of the study (questionnaires, pulmonary function test, 6 minutes walking test…); patients with difficulties to walk; patients with active infections or chronic inflammatory diseases; patients that reuse to participate in the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Osakidetza
OTHER
Sponsor Role
collaborator
Hospital Galdakao-Usansolo
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Dr. Cristobal Esteban
MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Cristobal Esteban, MD
Role: PRINCIPAL_INVESTIGATOR
Osakidetza
Locations
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Hospital Galdakao Usansolo
Galdakao, Vizcaya, Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
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Zemans RL, Jacobson S, Keene J, Kechris K, Miller BE, Tal-Singer R, Bowler RP. Multiple biomarkers predict disease severity, progression and mortality in COPD. Respir Res. 2017 Jun 13;18(1):117. doi: 10.1186/s12931-017-0597-7.
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BACKGROUND
Bafadhel M, McKenna S, Terry S, Mistry V, Reid C, Haldar P, McCormick M, Haldar K, Kebadze T, Duvoix A, Lindblad K, Patel H, Rugman P, Dodson P, Jenkins M, Saunders M, Newbold P, Green RH, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011 Sep 15;184(6):662-71. doi: 10.1164/rccm.201104-0597OC.
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Arostegui I, Esteban C, Garcia-Gutierrez S, Bare M, Fernandez-de-Larrea N, Briones E, Quintana JM; IRYSS-COPD Group. Subtypes of patients experiencing exacerbations of COPD and associations with outcomes. PLoS One. 2014 Jun 3;9(6):e98580. doi: 10.1371/journal.pone.0098580. eCollection 2014.
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BACKGROUND
Linssen J, Aderhold S, Nierhaus A, Frings D, Kaltschmidt C, Zanker K. Automation and validation of a rapid method to assess neutrophil and monocyte activation by routine fluorescence flow cytometry in vitro. Cytometry B Clin Cytom. 2008 Sep;74(5):295-309. doi: 10.1002/cyto.b.20422.
Reference Type
BACKGROUND
Cornet E, Boubaya M, Troussard X. Contribution of the new XN-1000 parameters NEUT-RI and NEUT-WY for managing patients with immature granulocytes. Int J Lab Hematol. 2015 Oct;37(5):e123-6. doi: 10.1111/ijlh.12372. Epub 2015 Apr 28. No abstract available.
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BACKGROUND
Buoro S, Seghezzi M, Vavassori M, Dominoni P, Apassiti Esposito S, Manenti B, Mecca T, Marchesi G, Castellucci E, Azzara G, Ottomano C, Lippi G. Clinical significance of cell population data (CPD) on Sysmex XN-9000 in septic patients with our without liver impairment. Ann Transl Med. 2016 Nov;4(21):418. doi: 10.21037/atm.2016.10.73.
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Urrechaga E, Boveda O, Aguirre U. Role of leucocytes cell population data in the early detection of sepsis. J Clin Pathol. 2018 Mar;71(3):259-266. doi: 10.1136/jclinpath-2017-204524. Epub 2017 Aug 18.
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Kaeslin M, Brunner S, Raths J, Huber A. Improvement in detecting bacterial infection in lower respiratory tract infections using the Intensive Care Infection Score (ICIS). J Lab Med 2016; 40: 175-182.
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Zhu Y, Cao X, Tao G, Xie W, Hu Z, Xu D. The lymph index: a potential hematological parameter for viral infection. Int J Infect Dis. 2013 Jul;17(7):e490-3. doi: 10.1016/j.ijid.2012.12.002. Epub 2013 Jan 10.
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Henriot I, Launay E, Boubaya M, Cremet L, Illiaquer M, Caillon H, Desjonqueres A, Gillet B, Bene MC, Eveillard M. New parameters on the hematology analyzer XN-10 (SysmexTM) allow to distinguish childhood bacterial and viral infections. Int J Lab Hematol. 2017 Feb;39(1):14-20. doi: 10.1111/ijlh.12562. Epub 2016 Aug 30.
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Xu D. Clinical Applications of Leukocyte Morphological Parameters Int J Pathol Clin Res 2015; 1:002
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Yao C, Liu X, Tang Z. Prognostic role of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio for hospital mortality in patients with AECOPD. Int J Chron Obstruct Pulmon Dis. 2017 Aug 3;12:2285-2290. doi: 10.2147/COPD.S141760. eCollection 2017.
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BACKGROUND
Paliogiannis P, Fois AG, Sotgia S, Mangoni AA, Zinellu E, Pirina P, Negri S, Carru C, Zinellu A. Neutrophil to lymphocyte ratio and clinical outcomes in COPD: recent evidence and future perspectives. Eur Respir Rev. 2018 Feb 7;27(147):170113. doi: 10.1183/16000617.0113-2017. Print 2018 Mar 31.
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Bafadhel M, Pavord ID, Russell REK. Eosinophils in COPD: just another biomarker? Lancet Respir Med. 2017 Sep;5(9):747-759. doi: 10.1016/S2213-2600(17)30217-5. Epub 2017 Jun 7.
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Vedel-Krogh S, Nielsen SF, Lange P, Vestbo J, Nordestgaard BG. Blood Eosinophils and Exacerbations in Chronic Obstructive Pulmonary Disease. The Copenhagen General Population Study. Am J Respir Crit Care Med. 2016 May 1;193(9):965-74. doi: 10.1164/rccm.201509-1869OC.
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Pascoe S, Locantore N, Dransfield MT, Barnes NC, Pavord ID. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med. 2015 Jun;3(6):435-42. doi: 10.1016/S2213-2600(15)00106-X. Epub 2015 Apr 12.
Reference Type
BACKGROUND
Other Identifiers
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G95756334
Identifier Type: -
Identifier Source: org_study_id
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