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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05999838
Other study ID # HR chest CT spirometry ILD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date February 2025

Study information

Verified date August 2023
Source Assiut University
Contact Dina W. Fahim, resident doctor
Phone 01287799134
Email tinawageh0@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To establish a simplified approach for assessment of severity of interstitial lung disease by evaluating the relationship between HRCT findings, the clinical severity score,spirometry and quality of life.


Description:

The interstitial lung diseases are a group of parenchymal pulmonary disorders that affect the interstitium causing progressive fibrosis of lung tissue. These disorders characterized by dyspnea aggravated by exertion . This group of diseases is associated with substantial morbidity and mortality. Thus, a multi-disciplinary approach including clinical, pathological, and radiological correlation is required to reach accurate assessment. The high-resolution computed tomography [HRCT] images of the chest are considered the main platform for the diagnostic approach .High-resolution CT (HRCT) scans offer the possibility of measuring disease severity more accurately and sensitively by focusing on fibrotic changes. HRCT images illustrate the presence and extent of parenchymal abnormalities including: reticular opacities, ground-glass opacities, traction bronchiectasis and honeycombing. Most patients with suspected ILDs are likely to undergo complete Pulmonary Function Testing. Usually there is restrictive pulmonary function with decreased TLC (Total Lung Capacity) , FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in One Second) and a normal or increased FEV1/FVC ratio.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date February 2025
Est. primary completion date October 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases among both sexes Exclusion Criteria: - patients under 18 years old. - pregnant patients. - patients with a history of previous lung resections. - presence of bronchial carcinoma or lobar consolidation. - patients contraindicated to perform pulmonary function will be excluded.

Study Design


Intervention

Diagnostic Test:
HRCT chest visual scoring
CT-based semi-quantitative scoring will be calculated according to number of lung segments affected on both sides. The finding on each segment will be given a score from 1 to 4 as follows: for ground glass opacities. for reticulations and fibrotic changes. for bronchiectatic changes. for honeycombing and sub-pleural cysts.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of visual based scoring system of HRCT and pulmonary function test. 1 year
Secondary assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs. 1 year
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