Interstitial Lung DiseaseNCT05999838
HR Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of ILD Patients
An observational study of Interstitial Lung Disease, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- HRCT chest visual scoring
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases
Who may be able to join
- All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases among both sexes
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Interstitial Lung Disease
- Being tested
- HRCT chest visual scoring
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRCT chest visual scoringDiagnostic test
Also called spirometry
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of visual based scoring system of HRCT and pulmonary function test.
Measured: 1 year
Secondary outcomes (1)
assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Wageeh Fahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999838
- Sponsor's protocol ID
- HR chest CT spirometry ILD
- Status last verified
- Aug 2023
- First submitted
- 11 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of Interstitial Lung Disease Patients
- ClinicalTrials.gov ID
- NCT05999838
- Acronym / sponsor ID
- HR chest CT spirometry ILD
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases
Key inclusion criteria (1 listed)
- All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases among both sexes
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRCT chest visual scoringAlso: spirometryCT-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: 1. for ground glass opacities. 2. for reticulations and fibrotic changes. 3. for bronchiectatic changes. 4. for honeycombing and sub-pleural cysts. | Diagnostic test | – |
Primary outcome
Correlation of visual based scoring system of HRCT and pulmonary function test.
Time frame: 1 year
1 secondary outcome
assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina W. Fahim, resident doctor (01287799134, tinawageh0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of visual based scoring system of HRCT and pulmonary function test. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.