Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-21 @ 11:11 PM
Study NCT ID:
NCT06680934
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2024-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CABP2 Patient Registry and Natural History Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001299', 'term': 'Audiometry'}], 'ancestors': [{'id': 'D006320', 'term': 'Hearing Tests'}, {'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-16', 'size': 218863, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-16T14:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '25 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2049-08-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2024-11-03', 'studyFirstSubmitQcDate': '2024-11-07', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2049-08-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pure-tone audiometry', 'timeFrame': '1 year, year 1, according to participant consent', 'description': "Pure tone audiometry is a behavioral hearing test used to measure an individual's hearing threshold levels"}, {'measure': 'Speech audiometry', 'timeFrame': '1 year, year 1, according to participant consent', 'description': "Speech audiometry is a test or series of tests to determine a patient's ability to discriminate speech sounds and hearing speech or speech in noise"}], 'secondaryOutcomes': [{'measure': 'Otoacoustic emission thresholds', 'timeFrame': '1 year, year 1, according to participant consent', 'description': 'Otoacoustic emission thresholds serve as indicators of integrity and function of the outer hair cells in the cochlea'}, {'measure': 'Auditory brainstem response', 'timeFrame': '1 year, year 1, according to participant consent', 'description': 'Auditory brainstem response tests the functional status of the auditory neural pathway'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CABP2 patient registry', 'Patient registry', 'DFNB93'], 'conditions': ['CABP2-related Auditory Synaptopathy', 'Hearing Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.auditory-neuroscience.uni-goettingen.de/cabp2_registry_en.html', 'label': 'Registry website in English'}, {'url': 'http://www.auditory-neuroscience.uni-goettingen.de/cabp2_registry.html', 'label': 'Registry website in German'}]}, 'descriptionModule': {'briefSummary': 'This registry is designed to collect comprehensive information about the molecular genetic diagnoses and clinical information of individuals with CABP2-associated hearing impairment to support a natural history study.', 'detailedDescription': 'A patient registry, in both German and English languages, has been established for patients with hereditary hearing impairment due to variants in CABP2. The study is conducted in accordance with the current version of the Declaration of Helsinki. The study protocol and database structure have been approved by the Ethics Committee of the University Medical Center Goettingen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with hearing impairment who have a molecular genetic diagnosis involving CABP2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A molecular genetic diagnosis involving biallelic variants in CAPB2 and audiometry\n\nExclusion Criteria:\n\n* Patients with evidence of non-CABP2 molecular genetic diagnoses'}, 'identificationModule': {'nctId': 'NCT06680934', 'briefTitle': 'CABP2 Patient Registry and Natural History Study', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Goettingen'}, 'officialTitle': 'Patient Registry for Individuals With CABP2-Associated Hearing Loss', 'orgStudyIdInfo': {'id': '17/8/22 v2.1 - 2023-02528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CABP2 participant group', 'description': 'Individuals with hearing impairment who have a molecular genetic diagnosis involving CABP2', 'interventionNames': ['Diagnostic Test: Molecular genetic testing and audiometry']}], 'interventions': [{'name': 'Molecular genetic testing and audiometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Genetic testing and audiometry are the interventions of interest', 'armGroupLabels': ['CABP2 participant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Barbara Vona, PhD', 'role': 'CONTACT', 'email': 'barbara.vona@med.uni-goettingen.de', 'phone': '+49-551-38-51337'}, {'name': 'Tobias Moser, MD', 'role': 'CONTACT', 'email': 'tmoser@gwdg.de', 'phone': '+49-551-39-63070'}, {'name': 'Tobias Moser, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bernd Wollnik, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicola Strenzke, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Barbara Vona, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'centralContacts': [{'name': 'Barbara Vona, PhD', 'role': 'CONTACT', 'email': 'barbara.vona@med.uni-goettingen.de', 'phone': '+49-551-38-51337'}, {'name': 'Tobias Moser, MD', 'role': 'CONTACT', 'email': 'tmoser@gwdg.de', 'phone': '+49-551-39-63070'}], 'overallOfficials': [{'name': 'Tobias Moser, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center Goettingen'}, {'name': 'Bernd Wollnik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Goettingen'}, {'name': 'Nicola Strenzke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Goettingen'}, {'name': 'Barbara Vona, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Goettingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Pseudonymized data will be published in publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Goettingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Tobias Moser', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}