Interstitial Lung DiseaseNCT04676594
Genentech Validation Tool for Pulmonary Fibrosis
An observational study of Interstitial Lung Disease, run by Columbia University at 1 site in United States.
Trial summary
Radiology is an important component of the multidisciplinary team. The primary goal of this project will be to create a tool using findings on chest computed tomography (CT) for nearly 300 patients with the most common types of fibrosis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2020to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Adult, Older adult
Study population: Patients with a diagnosis of usual interstitial pneumonitis, Chronic hypersensitivity pneumonitis or nonspecific interstitial pneumonitis and a chest CT scan.
Who may be able to join
- Retrospective review of adults (age > 21) with diagnosis of pulmonary fibrosis on chest CT and a pulmonologist report in electronic medical record confirming the working diagnosis from 1/1/2010 through 7/1/2019.
Who cannot join
- Failure to meet inclusion criteria including age < 21 and lack of a pulmonologists report in the medical record with a working diagnosis of patient's type of pulmonary fibrosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Validation of a Radiologic Tool for Diagnosing Pulmonary Fibrosis
Radiology is an important component of the multidisciplinary team. The primary goal of this project will be to create a tool using findings on chest computed tomography (CT) for nearly 300 patients with the most common types of fibrosis. The tool will be tested using chest CT scans of an additional 100 patients with the 3 most common diagnoses of fibrosis. The second objective will be to further validate the tool by performing a reader study with 3 co-investigating radiologists and ask them to look at 100 CT scans of patients with fibrosis without tool and then with tool and see if accuracy of diagnosis improves compared to the working diagnosis when using the tool.
- Conditions
- Interstitial Lung Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of Pulmonary Fibrosis on Chest CT | Retrospective chart review of patients with a diagnosis of pulmonary fibrosis on chest CT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations Between Patterns for CT Scan Features
Creation of the radiologic diagnostic tool will be identified via statistical analysis of patterns for CT scan features. The patterns will be characterized using latent class analysis (LCA) and the demographic factors that are predictive of each pattern will be identified. Associations between patterns for CT scan features identified using LCA and the disease diagnosis will then be assessed using the Fisher's exact test.
Measured: Up to 6 months
Secondary outcomes (2)
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic Tool
The cumulative number of accurate (correct) diagnoses of fibrosis type (interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), or chronic hypersensitivity pneumonitis) without the diagnostic tool. Each assessment will be coded as correct or incorrect by comparing to the true disease diagnosis.
Measured: Up to 6 months
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic Tool
Cumulative number of accurate (correct) diagnoses of fibrosis type (interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), or chronic hypersensitivity pneumonitis) with the diagnostic tool. Each assessment will be coded as correct or incorrect by comparing to the true disease diagnosis.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start4 Oct 2020
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (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 Columbia 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676594
- Sponsor's protocol ID
- AAAS7955
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2020
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Radiologic Tool for Diagnosing Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04676594
- Acronym / sponsor ID
- AAAS7955
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Dec 2020 (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.
Radiology is an important component of the multidisciplinary team. The primary goal of this project will be to create a tool using findings on chest computed tomography (CT) for nearly 300 patients with the most common types of fibrosis. The tool will be tested using chest CT scans of an additional 100 patients with the 3 most common diagnoses of fibrosis. The second objective will be to further validate the tool by performing a reader study with 3 co-investigating radiologists and ask them to look at 100 CT scans of patients with fibrosis without tool and then with tool and see if accuracy of diagnosis improves compared to the working diagnosis when using the tool.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of Pulmonary Fibrosis on Chest CT | – | –Retrospective chart review of patients with a diagnosis of pulmonary fibrosis on chest CT. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of usual interstitial pneumonitis, Chronic hypersensitivity pneumonitis or nonspecific interstitial pneumonitis and a chest CT scan.
Key inclusion criteria (1 listed)
- Retrospective review of adults (age > 21) with diagnosis of pulmonary fibrosis on chest CT and a pulmonologist report in electronic medical record confirming the working diagnosis from 1/1/2010 through 7/1/2019.
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria including age < 21 and lack of a pulmonologists report in the medical record with a working diagnosis of patient's type of pulmonary fibrosis.
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
Associations Between Patterns for CT Scan Features
Time frame: Up to 6 months
Creation of the radiologic diagnostic tool will be identified via statistical analysis of patterns for CT scan features. The patterns will be characterized using latent class analysis (LCA) and the demographic factors that are predictive of each pattern will be identified. Associations between patterns for CT scan features identified using LCA and the disease diagnosis will then be assessed using the Fisher's exact test.
2 secondary outcomes
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic Tool
Time frame: Up to 6 months
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic Tool
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Columbia University at 1 site in United States.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Associations Between Patterns for CT Scan Features (time frame: Up to 6 months). 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 3 Sep 2026.