NCT05760508

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3.7 years

First QC Date

February 10, 2023

Last Update Submit

February 27, 2023

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with a diagnosis of ILD

You may qualify if:

  • diagnosis of ILD, made according to international guidelines where available
  • age between 40 and 90 years

You may not qualify if:

  • significant comorbidities or physical impairment that could affect participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2023

First Posted

March 8, 2023

Study Start

July 23, 2018

Primary Completion

March 30, 2022

Study Completion

January 1, 2024

Last Updated

March 8, 2023

Record last verified: 2023-02

Locations

IT(1)