Genentech Validation Tool for Pulmonary Fibrosis

NCT04676594 | Active Not Recruiting

• 1 other identifier: AAAS7955
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months

Secondary Outcomes (2)

• Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic Tool

  Up to 6 months

• Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic Tool

  Up to 6 months

Study Arms (1)

Diagnosis of Pulmonary Fibrosis on Chest CT

Retrospective chart review of patients with a diagnosis of pulmonary fibrosis on chest CT.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of usual interstitial pneumonitis, Chronic hypersensitivity pneumonitis or nonspecific interstitial pneumonitis and a chest CT scan.

You may qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mary Salvatore, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: October 4, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)