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Morphological Parameters of Blood Cell's Activation in Characterization and Prognosis in a COPD Patients Cohort

NCT04923360 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-06-11

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Osakidetza

    collaborator OTHER

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • Cristobal Esteban, MD · Osakidetza

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-01-01
Completion
2022-06-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04923360 on ClinicalTrials.gov