Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-01 @ 12:18 AM
Study NCT ID:
NCT04104594
Status:
TERMINATED
Last Update Posted:
2022-10-25
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009298', 'term': 'Nasal Polyps'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012903', 'term': 'Smell'}, {'id': 'D000079602', 'term': 'Sino-Nasal Outcome Test'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000071066', 'term': 'Patient Reported Outcome Measures'}, {'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D063868', 'term': 'Patient Outcome Assessment'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control and patients'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'The laboratory in which the analyses on nasosinusal polyposis were to be carried out did not want to continue the research on this subject, so it was decided to stop this study prematurely.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'expression rate of TNF-alpha in biopsies', 'timeFrame': '2 months', 'description': 'The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score.'}, {'measure': 'Sniffin Stick test score', 'timeFrame': '2 months', 'description': 'The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score.\n\nSniffin Stick test score :\n\nThe final score, out of 48, is the sum of the olfactory threshold (out of 16), discrimination (out of 16) and identification (out of 16) scores.\n\nNormal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.'}], 'secondaryOutcomes': [{'measure': 'Olfactory Cleft Endoscopic Score', 'timeFrame': '2 months', 'description': 'measured at control and patients. 5 endoscopic feature to be completed :\n\n* discharge : 0= none or scant clear/thin drainage (normal) ; 1= more abundant, thicker clear/white drainage (not normal but not purulent) ; 2= thicker, more abundant, discolored/purulent drainage.\n* polyps : 0= none ; 1= discrete polyps partially narrowing/blocking the olfactory cleft (\\<50%) ; 2= discrete polyps completely narrowing/blocking the olfactory cleft (\\>50%).\n* edema : 0= none ; 1= swelling partially narrowing/blocking the olfactory cleft (\\<50%) ; 2= swelling completely narrowing/blocking the olfactory cleft (\\>50%).\n* crusting : 0= none ; 1= mild ; 2= severe\n* scarring : 0= none ; 1= mild ; 2= severe'}, {'measure': 'expression rate of TNF-alpha in polyps', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}, {'measure': 'dosage of cytokines G-CSF', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}, {'measure': 'dosage of cytokines GM-CSF', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}, {'measure': 'dosage of cytokines IFN-γ', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}, {'measure': 'dosage of cytokines IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}, {'measure': 'dosage of cytokines MCP-1', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}, {'measure': 'dosage of cytokines MIP-1β', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}, {'measure': 'dosage of cytokines MCAF', 'timeFrame': '2 months', 'description': 'measured at control and patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TNF alpha'], 'conditions': ['Nasal Polyps', 'Chronic Rhinosinusitis With Nasal Polyps', 'Olfaction Disorders']}, 'descriptionModule': {'briefSummary': 'Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for patients :\n\n* Patients with nasosinus polyposis requiring nasosinus surgery\n* Patient affiliated or entitled to a social security\n* signed consent\n\nInclusion Criteria for control group :\n\n* Patients with an indication for septoplasty\n* Patient affiliated or entitled to a social security\n* signed consent\n\nExclusion Criteria for patients :\n\n* Patients with nasosinus polyposis secondary to another disease\n* Patients with hyposmia or anosmia prior to naso-sinus polyposis\n* Patients with diagnosed neurodegenerative disease\n* Patients who are mentally or physically unable to perform olfactory tests\n* Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.\n\nExclusion Criteria for control group :\n\n* Patients with nasosinus polyposis\n* Patients with chronic rhino-sinusitis\n* Patients with hyposmia or anosmia\n* Patients with diagnosed neurodegenerative disease\n* Patients who are mentally or physically unable to perform olfactory tests\n* Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.'}, 'identificationModule': {'nctId': 'NCT04104594', 'acronym': 'OIPN', 'briefTitle': 'Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps', 'orgStudyIdInfo': {'id': '19CH099'}, 'secondaryIdInfos': [{'id': '2019-A01625-52', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with chronic rhinosinusitis with nasal polyps', 'interventionNames': ['Diagnostic Test: Sniffin Stick Test', 'Other: numerical evaluation scale for olfaction', 'Other: numerical evaluation scale for nasal obstruction', 'Other: nasal outcome test', 'Biological: dosage of 17 cytokines']}, {'type': 'OTHER', 'label': 'Patients with an indication for septoplasty = control group', 'interventionNames': ['Diagnostic Test: Sniffin Stick Test', 'Other: nasal outcome test', 'Biological: dosage of 17 cytokines']}], 'interventions': [{'name': 'Sniffin Stick Test', 'type': 'DIAGNOSTIC_TEST', 'description': "The test consists of odorous rods that are presented to the patient's nose. It consists of 3 parts different, with 3 sets of corresponding sticks: an olfactory threshold test, an olfactory discrimination test and an olfactory identification test.\n\nThe final score, out of 48, is the sum of the olfactory threshold, discrimination and identification scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.", 'armGroupLabels': ['Patients with an indication for septoplasty = control group', 'patients with chronic rhinosinusitis with nasal polyps']}, {'name': 'numerical evaluation scale for olfaction', 'type': 'OTHER', 'description': 'numerical rating scale from 0 (no smell) to 10 (perfect smell)', 'armGroupLabels': ['patients with chronic rhinosinusitis with nasal polyps']}, {'name': 'numerical evaluation scale for nasal obstruction', 'type': 'OTHER', 'description': 'numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)', 'armGroupLabels': ['patients with chronic rhinosinusitis with nasal polyps']}, {'name': 'nasal outcome test', 'type': 'OTHER', 'description': 'list of symptoms and social/emotional consequences of rhino-sinusitis. 16 questions that the patient must code from "no problem" to "serious problem" over the last 15 days', 'armGroupLabels': ['Patients with an indication for septoplasty = control group', 'patients with chronic rhinosinusitis with nasal polyps']}, {'name': 'dosage of 17 cytokines', 'type': 'BIOLOGICAL', 'description': 'dosage of 17 cytokines : G-CSF, GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, IL-17A, MCP-1 (MCAF), MIP-1β,TNF-α', 'armGroupLabels': ['Patients with an indication for septoplasty = control group', 'patients with chronic rhinosinusitis with nasal polyps']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Marie GAVID, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}