Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-04-07 @ 12:55 AM
Study NCT ID:
NCT00899561
Status:
UNKNOWN
Last Update Posted:
2012-03-19
First Post:
2009-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010019', 'term': 'Osteomyelitis'}, {'id': 'D011127', 'term': 'Polyps'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Middle turbinate samples of patients with limited, intermediate, and extensive chronic sinus disease.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-16', 'studyFirstSubmitDate': '2009-05-11', 'studyFirstSubmitQcDate': '2009-05-11', 'lastUpdatePostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inflammation of soft tissue and bony elements of the middle turbinate', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic rhinosinusitis', 'Computed tomography', 'Histology', 'Middle turbinate', 'Morphometry', 'osteomyelitis', 'polyps'], 'conditions': ['Chronic Rhinosinusitis']}, 'descriptionModule': {'briefSummary': "In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group.\n\nThe investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with a limited (of 1-8), intermediate (9-16), and extensive (17-24) sinus disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with chronic rhinosinusitis who failed conservative medical treatment,\n* Patients who stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.\n\nExclusion Criteria:\n\n* Immunosuppressed patients,\n* Patients in whom no indication to excise the middle turbinate was found, AND\n* Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).'}, 'identificationModule': {'nctId': 'NCT00899561', 'acronym': 'CT', 'briefTitle': 'Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Correlation Between Middle Turbinate Histopathology and Computed Tomography Staging in Chronic Rhinosinusitis', 'orgStudyIdInfo': {'id': 'MeirMc'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gilead Berger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gilead Berger, MD', 'role': 'CONTACT', 'email': 'berger45@netvision.net.il'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Gilead Berger, MD', 'role': 'CONTACT', 'email': 'berger45@netvision.net.il'}], 'overallOfficials': [{'name': 'Gilead Berger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}, {'name': 'Roee Landsberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}