Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is: • Can a machine-learning based algorithm be developed that can classify the extent of emphysema on chest CT scan from patients with COPD, based on voice and/or capnometry. Participants will: * perform different voice-related tasks * perform capnometry twice (before/after exercise) * perform a light exercise task between tasks ( 5-sit-to-stand test) * undergo one venipuncture

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged over 18 years

• current respiratory smptoms (any dyspnea, cough or sputum)

• spirometry confirmed diagnosis of a non-fully reversible airflow obstruction, defined as a post bronchodilator Forced Expiratory Volume at one second/Forced Vital Capacity (FEV1/FVC ratio) \< 0.7 and/or emphysemateus abnormalities on CT imaging.

• presence of risk factors or causes associated with COPD

• chest CT scan performed in the past 12 months prior to inclusion to the study

• able to understand, read and write Dutch language

Locations
Other Locations
Netherlands
Dept of Respiratory Medicine, Maastricht University Medical Centre
RECRUITING
Maastricht
Laurentius Ziekenhuis
NOT_YET_RECRUITING
Roermond
Contact Information
Primary
Sami Simons, MD PhD
sami.simons@mumc.nl
+31 043 3876543
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2026-05
Participants
Target number of participants: 200
Treatments
COPD and/or emphysema
COPD is defined according to COPD Gold 2023 guidelines. Emphysema defined acording to Fleischner criteria (2024)
Sponsors
Collaborators: Roche Pharma AG
Leads: Maastricht University

This content was sourced from clinicaltrials.gov