Interstitial Lung DiseaseNCT06260930
Value of Chest Ultrasonography in ILD Screening
An observational study of Interstitial Lung Disease, run by Aswan University.
Trial summary
The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Eligible patients will be recruited from the Department of Chest, Aswan University Hospital
Who may be able to join
- Adults (≥18 years) diagnosed with ILD
- All patients must fulfil the 2018 criteria for HRCT chest finding for the diagnosis of Usual interstitial pneumonia (UIP) form
Who cannot join
- Patients with cardiac diseases (Left-sided Heart failure, pulmonary edema) [they may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings].
- Patients with chronic kidney diseases (as patients presented with nephrogenic pulmonary edema may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings).
About this study
Official title: Role od Chest Ultrasonography in Interstitial Lung Diseases
The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation.
Read the detailed description
Interstitial lung disease (ILD) refers to a group of disorders that are characterized by varying combinations of inflammation and fibrosis involving the space between the epithelial and endothelial basement membranes.
- Conditions
- Interstitial Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the lung sonography for interstitial lung disease screening
To estimate the sensitivity and specificity of the lung sonography for interstitial disease screening in comparison with HRCT. [Time Frame: 12 months]
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study startJan 2017
- Primary completionSep 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazly Ahmed, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260930
- Sponsor's protocol ID
- Value of chest ultrasonography
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deconinck B, Verschakelen J, Coolen J, Verbeken E, Verleden G, Wuyts W. Diagnostic workup for diffuse parenchymal lung disease: schematic flowchart, literature review, and pitfalls. Lung. 2013 Feb;191(1):19-25. doi: 10.1007/s00408-012-9433-5. Epub 2012 Nov 13.
PubMed 23149802
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role od Chest Ultrasonography in Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT06260930
- Acronym / sponsor ID
- Value of chest ultrasonography
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 Feb 2024 (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.
The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation.
Detailed description
Interstitial lung disease (ILD) refers to a group of disorders that are characterized by varying combinations of inflammation and fibrosis involving the space between the epithelial and endothelial basement membranes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be recruited from the Department of Chest, Aswan University Hospital
Key inclusion criteria (2 listed)
- Adults (≥18 years) diagnosed with ILD
- All patients must fulfil the 2018 criteria for HRCT chest finding for the diagnosis of Usual interstitial pneumonia (UIP) form
Key exclusion criteria (2 listed)
- Patients with cardiac diseases (Left-sided Heart failure, pulmonary edema) [they may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings].
- Patients with chronic kidney diseases (as patients presented with nephrogenic pulmonary edema may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of the lung sonography for interstitial lung disease screening
Time frame: 12 months
To estimate the sensitivity and specificity of the lung sonography for interstitial disease screening in comparison with HRCT. [Time Frame: 12 months]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 23149802Deconinck B, Verschakelen J, Coolen J, Verbeken E, Verleden G, Wuyts W. Diagnostic workup for diffuse parenchymal lung disease: schematic flowchart, literature review, and pitfalls. Lung. 2013 Feb;191(1):19-25. doi: 10.1007/s00408-012-9433-5. Epub 2012 Nov 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Aswan 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the lung sonography for interstitial lung disease screening (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260930, which also lists 1 linked publication.
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 15 Feb 2024.