Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-02 @ 10:57 AM
Study NCT ID:
NCT06678334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-07
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristic Transcriptomic, Proteomic and Metabolomic Molecular Studies of Nasal Secretions From Chronic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collection of plasma and nasal secretions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2032-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The signature transcriptomic, proteomic, and metabolomic indicators or combinations of nasal secretions of different subtypes of chronic rhinitis', 'timeFrame': '3 years', 'description': 'The signature transcriptomic, proteomic, and metabolomic indicators or combinations of nasal secretions of different subtypes of chronic rhinitis, which have high sensitivity and specificity in the diagnosis of a specific chronic rhinitis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Rhinitis']}, 'descriptionModule': {'briefSummary': 'Chronic rhinitis is a common chronic nasal mucosal inflammatory disease. Its clinical symptoms and severity are diverse, mainly including allergic rhinitis, local allergic rhinitis, non-allergic rhinitis with hypereosinophilia syndrome and idiopathic rhinitis. All kinds of rhinitis have clinical symptoms such as nasal congestion, runny nose, sneezing, and nasal itching, but the causes are different. At present, the complicated diagnostic methods of different subtypes of chronic rhinitis are an important factor restricting the improvement of clinical diagnosis and treatment. Based on the found key markers of each subtype of chronic rhinitis, the establishment of a non-invasive classification diagnostic method of chronic rhinitis with nasal secretion as the core is of great practical significance for optimizing the existing clinical diagnosis system and improving the efficiency of clinical diagnosis', 'detailedDescription': 'To study the characteristic transcriptome, proteome and metabolome molecules of nasal secretions of different subtypes of chronic rhinitis, and to establish a non-invasive diagnostic method for chronic rhinitis based on nasal secretions.Nasal secretions and blood were collected from patients with chronic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Patients in the First Affiliated Hospital, Nanjing Medical University and volunteering for this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 years old;\n2. Patients with chronic rhinitis in the Department of Otorhinolaryngology, the First Affiliated Hospital of Nanjing Medical University;\n3. Patients who are willing to provide specimens for free to promote the diagnosis of chronic rhinitis.\n\nExclusion Criteria:\n\n1. Patients received glucocorticoids, immunomodulatory drugs, antihistamines, and other treatments that may affect the study results within the past 1 month.\n2. Patients with unstable diseases (including severe asthma) and active immune system diseases;\n3. Smoking;\n4. Pregnant or lactating women; History of nasal surgery within 5.3 months;\n\n6\\. Patients with low compliance and refusing to accept specimen and questionnaire collection'}, 'identificationModule': {'nctId': 'NCT06678334', 'briefTitle': 'Characteristic Transcriptomic, Proteomic and Metabolomic Molecular Studies of Nasal Secretions From Chronic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Characterization of Transcriptome, Proteome and Metabolome Molecules in Nasal Secretions of Different Subtypes of Chronic Rhinitis', 'orgStudyIdInfo': {'id': '2024-SR-580'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic rhinitis', 'description': 'In this study, no additional intervention was performed on the patients. Only nasal secretions and blood samples were collected from patients with chronic rhinitis in our hospital.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lei Cheng, PhD', 'role': 'CONTACT', 'email': 'chenglei@jsph.org.cn', 'phone': '+8613776620807'}, {'name': 'Yanbing Chen MBBS, MBBS', 'role': 'CONTACT', 'email': '1163259065@qq.com', 'phone': '+8615851875990'}], 'overallOfficials': [{'name': 'Lei Cheng, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital, Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All the individual participant data only available to reasearchers participated in this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD', 'investigatorFullName': 'Cheng Lei', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}