- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05999838
HR Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of ILD Patients
August 10, 2023 updated by: Dina Wageeh Fahim, Assiut University
High-resolution Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of Interstitial Lung Disease Patients
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dina W. Fahim, resident doctor
- Phone Number: 01287799134
- Email: tinawageh0@gmail.com
Study Contact Backup
- Name: Nermeen M. Abu Elkassem, Lecturer
- Phone Number: 01000767713
- Email: nermenabuelkassem@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation of visual based scoring system of HRCT and pulmonary function test.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
July 11, 2023
First Submitted That Met QC Criteria
August 10, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 10, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR chest CT spirometry ILD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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