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NCT05760508 Clinical Trial

Novel Markers of Disease Progression in Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

— NOMAD  

Official title:
Novel Markers of Disease Progression in Interstitial Lung Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05760508
Other study ID # 2104
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 23, 2018
Est. completion date January 2024

Study information
Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study design: A prospective cohort study with a longitudinal design, with several parameters measured serially at baseline and at pre-specified time points during three to five years of clinical observation. Primary objective: To validate quantitative analysis of lung sounds as a marker of disease progression in a cohort of patients with Interstitial Lung Disease (ILD) via correlation with the extent of fibrosis on HRCT, measured both via visual scoring and quantitative CT assessment, and other validated parameters of disease progression such as FVC, tolerance to exercise and patient-related outcomes (symptoms and quality of life). Secondary objectives: To determine the prognostic value of quantitative analysis of lung sounds and a series of novel putative biological markers, obtained from peripheral blood and bronchoalveolar lavage, toward poor outcomes (death, categorical decline of % predicted FVC >10%, acute exacerbation or respiratory-related hospitalisations) as compared to more conventional clinical, physiology and radiologic measurements.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date January 2024
Est. primary completion date March 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria: - diagnosis of ILD, made according to international guidelines where available - age between 40 and 90 years Exclusion Criteria: - significant comorbidities or physical impairment that could affect participation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Fondazione Policlinico Agostino Gemelli IRCCS Rome Roma

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease progression Validate quantitative analysis of lung sounds as a marker of disease progression via correlation with the extent of fibrosis on HRCT, measured both via visual scoring and quantitative CT assessment, and other validated parameters of disease progression such as FVC, tolerance to exercise and patient-related outcomes. 3 years
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