Genentech Validation Tool for Pulmonary Fibrosis

NCT ID: NCT04676594

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-04

Study Completion Date

2026-08-31

Brief Summary

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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

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Conditions

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Interstitial Lung Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Diagnosis of Pulmonary Fibrosis on Chest CT

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Salvatore, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAS7955

Identifier Type: -

Identifier Source: org_study_id