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Genentech Validation Tool for Pulmonary Fibrosis

Validation of a Radiologic Tool for Diagnosing Pulmonary Fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04676594
Enrollment
400
Registered
2020-12-21
Start date
2020-10-04
Completion date
2027-08-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Brief 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. 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.

Interventions

None listed

Sponsors

Columbia University
Lead SponsorOTHER
Genentech, Inc.
CollaboratorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Associations Between Patterns for CT Scan FeaturesUp to 6 monthsCreation 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.

Secondary

MeasureTime frameDescription
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic ToolUp to 6 monthsThe 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.
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic ToolUp to 6 monthsCumulative 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026