Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 9:09 AM
Study NCT ID:
NCT05747235
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Computed Tomography in the Phenotyping of COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identifying the different phenotypes of COPD using HRCT', 'timeFrame': 'one month', 'description': 'Identifying the different phenotypes of COPD using HRCT. moreover, to identify whether there is a possible correlation between CT phenotypes and FEV1, FVC or FEV1/FVC.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '23711228', 'type': 'BACKGROUND', 'citation': 'Fan L, Xia Y, Guan Y, Zhang TF, Liu SY. Characteristic features of pulmonary function test, CT volume analysis and MR perfusion imaging in COPD patients with different HRCT phenotypes. Clin Respir J. 2014 Jan;8(1):45-54. doi: 10.1111/crj.12033. Epub 2013 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease that is characterized by respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. the CT was used for classification of COPD patients into different phenotypes: phenotype A that has minimal emphysema with or without airway disease, phenotype E that has emphysema without airway disease, and finally phenotype M as a mixed form. The investigators aimed to to identify the phenotypes of COPD using radiologic data obtained by computed tomography. Moreover, this study will be designed to answer the questions about possible correlation between pulmonary function parameters and CT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).and able to perform MSCT', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).\n* Age above 18 years.\n\nExclusion Criteria:\n\n* COPD patients associated with other chest diseases as collapse\n* COPD patients associated with consolidation\n* COPD patients unable to perform spirometry'}, 'identificationModule': {'nctId': 'NCT05747235', 'briefTitle': 'The Role of Computed Tomography in the Phenotyping of COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University'}, 'officialTitle': 'The Role of Computed Tomography in the Phenotyping of COPD Patients', 'orgStudyIdInfo': {'id': 'CT in COPD phenotyping'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT chest', 'type': 'RADIATION', 'description': 'All patients will undergo MSCT chest at both inspiratory and expiratory phases in supine position without any contrast media.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Islam Galal Sayed', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Islam Galal Sayed', 'investigatorAffiliation': 'Aswan University'}}}}