Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT04676594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genentech Validation Tool for Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Associations Between Patterns for CT Scan Features', 'timeFrame': 'Up to 6 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': "Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic Tool", 'timeFrame': 'Up to 6 months', 'description': '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.'}, {'measure': "Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic Tool", 'timeFrame': 'Up to 6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of usual interstitial pneumonitis, Chronic hypersensitivity pneumonitis or nonspecific interstitial pneumonitis and a chest CT scan.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT04676594', 'briefTitle': 'Genentech Validation Tool for Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Validation of a Radiologic Tool for Diagnosing Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'AAAS7955'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnosis of Pulmonary Fibrosis on Chest CT', 'description': 'Retrospective chart review of patients with a diagnosis of pulmonary fibrosis on chest CT.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mary Salvatore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}