Genentech Validation Tool for Pulmonary Fibrosis

Recruiting

• Conditions: Interstitial Lung Disease

• Registration Number: NCT04676594
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-04
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Associations Between Patterns for CT Scan Features	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic Tool	Up to 6 months	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.
Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic Tool	Up to 6 months	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States