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UnknownNCT03337854

Analysis With Clusters of QUAntitative Tomodensitometric Vascular, bronchIal and Parenchymal Pulmonary Parameters for COPD Patients

Status
Unknown
Phase
Study type
Observational
Enrollment
270 (estimated)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to characterize on clinical and radiological data, using computed tomography, this illness in order to improve diagnostic and be able to evaluate the prognostic of each patient.

Detailed description

Chronic obstructive pulmonary disease (COPD) is characterized by emphysematous destruction of pulmonary parenchyma, airway obstruction that participate in chronic temporary obstruction of airways. COPD has multiple clinical presentations that define phenotypes but doesn't take into account those anatomo-pathologic modifications. Moreover, the prognostic interest of those structural alteration is unknown. Until now, only PFT allowed to define the severity of the disease, whereas multiple others tools may be useful, such as, symptoms scores, exacerbation frequencies, denutrition. Those structural alterations are available using computed tomography (CT), that may also have an interest in prognostic or in treatment follow- up. CT is widely used in clinical practice for COPD patients at basal state and in exacerbations. Quantitative CT is able to combine acquisition of objective and reproductible informations on parenchymal destruction (emphysema), bronchial wall remodeling, and pulmonary vessels alteration. The investigators' team developed software tools to determine quantitative structural modifications of airways, emphysema and small pulmonary vessels1,2. The team has been able to build a score "Paw score" combining PaO2 with CT parameters of bronchial wall thickness and small pulmonary vessels percentage2. This score allowed to predict the presence of severe pulmonary hypertension in patients with COPD. Pulmonary hypertension is a complication of COPD that increase morbi-mortality. The hypothesis is that morphological quantitative analysis combined with structural alterations of airways has a prognostic interest. The main goal is to determine morphological phenotypes of COPD using a cluster analysis combining emphysema, bronchial wall thickness and pulmonary vessels. The other main goal is to predict evolution of COPD patients based on clinical outcomes (exacerbations frequency, mortality, mMRC, SGQLQ) and lung function testing (decline in FEV-1 TLCO, PaO2). The team also wants to analyze clinical data of survival, exacerbation and symptoms in following years of the CT of each cluster in historic-prospective way. The secondary goals are to describe clinical, functional and biological clusters. Analyse of correlations will be studied. Moreover, we will investigate the interest of the "Paw score" as a prognostic marker and as a correlated parameter. This is a retrospective study. We want to take information from the year before CT, to the year after CT. At the date of the consultation concomitant with CT we want to know all the clinical, functional and biological data of each patient.

Conditions

Timeline

Start date
2017-12-20
Primary completion
2018-01-01
Completion
2018-12-01
First posted
2017-11-09
Last updated
2017-11-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03337854. Inclusion in this directory is not an endorsement.