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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04676594
Other study ID # AAAS7955
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 4, 2020
Est. completion date October 30, 2024

Study information

Verified date April 2024
Source Columbia University
Contact Mary Salvatore, MD
Phone 212-317-4819
Email ms5680@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers
Gender All
Age group 21 Years and older
Eligibility 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


Locations

Country Name City State
United States Columbia University Irving Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Up to 6 months
Secondary 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. Up to 6 months
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