Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 5:37 PM
Study NCT ID:
NCT05409833
Status:
UNKNOWN
Last Update Posted:
2023-10-19
First Post:
2022-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C567782', 'term': 'Amyloidosis, Hereditary, Transthyretin-Related'}, {'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'biopsy and peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of transthyretin amyloidosis in synovial in patients with ≥60 years old', 'timeFrame': '24 months', 'description': 'Number of patients with transthyretin amyloidosis in synovial in relation to total number of patients submitted to hand surgery'}], 'secondaryOutcomes': [{'measure': 'Association between synovial transthyretin amyloidosis with carpal tunnel syndrome', 'timeFrame': '24 months', 'description': 'Comparison between group 1 and 2'}, {'measure': 'Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis', 'timeFrame': '24 months', 'description': 'Comparison between group 1 and 2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transthyretin Amyloidosis', 'Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Systemic transthyretin amyloidosis is an aging-related disorder. It is usually associated with cardiac disease but also extends to other organs. Recent studies found that idiopathic carpal tunnel syndrome patients may have amyloid deposition in tenosynovial tissue. The main aims of this project are the characterization of the association between idiopathic carpal tunnel syndrome and transthyretin amyloidosis and its evaluation as a predictive factor of cardiac amyloidosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ≥60 years old submitted to hand surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n. Patients aged ≥ 60 years old with symptomatic idiopathic carpal tunnel syndrome or other hand surgery indications.\n\nExclusion Criteria:\n\n. Diabetes mellitus, hypothyroidism, hemodialysis, rheumatoid arthritis, and other inflammatory arthropathies, multiple myeloma, gout, chondrocalcinosis, Colles fracture, space-occupying lesions, and infectious synovitis.'}, 'identificationModule': {'nctId': 'NCT05409833', 'acronym': 'CarPoS', 'briefTitle': 'Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population (CarPoS Study)', 'orgStudyIdInfo': {'id': 'CarPoS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients aged ≥ 60 years old with symptomatic carpal tunnel syndrome submitted to surgery', 'interventionNames': ['Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD']}, {'label': 'Group 2', 'description': 'Patients aged ≥ 60 years old without symptomatic carpal tunnel syndrome submitted to hand surgery', 'interventionNames': ['Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD']}], 'interventions': [{'name': 'Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD', 'type': 'DIAGNOSTIC_TEST', 'description': 'Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-319', 'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Elisabete Martins, MD, PhD', 'role': 'CONTACT', 'email': 'ebernardes@med.up.pt', 'phone': '(+351) 965913480'}, {'name': 'Elisabete Martins, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sofia Pimenta, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centro Hospitalar Universitário São João', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4200-319', 'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Janete Santos, PhD', 'role': 'CONTACT', 'email': 'investigaclinica@med.up.pt', 'phone': '(+351) 225 513 600'}], 'facility': 'Faculty of Medicine (FMUP)', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Elisabete Martins, MD, PhD', 'role': 'CONTACT', 'email': 'ebernardes@med.up.pt', 'phone': '(+351) 965913480'}, {'name': 'Janete Santos, PhD', 'role': 'CONTACT', 'email': 'investigaclinica@med.up.pt', 'phone': '(+351) 225 513 600'}], 'overallOfficials': [{'name': 'Elisabete Martins, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Hospitalar De São João, E.P.E.', 'class': 'OTHER'}, {'name': 'Centro de Investigação em Tecnologias e Serviços de Saúde', 'class': 'OTHER'}, {'name': 'Rede de Investigação em Saúde', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}