Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03966105
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2019-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Wild Type ATTR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Report the prevalence of ATTRwt in patients with CTS and/or LSS.', 'timeFrame': '2 years', 'description': 'Prevalence of ATTRwt in a prospective population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wild-type TTR amyloidosis', 'lumbar spinal stenosis', 'prevalence'], 'conditions': ['Wild-type Transthyretin Amyloidosis']}, 'descriptionModule': {'briefSummary': 'Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).', 'detailedDescription': 'The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective population of 100 patients undergoing LSS surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI\n* Availability of the baseline and follow-up annotations\n* Informed consent will be obtained from the patient before any study related procedures\n\nExclusion Criteria:\n\n* Previous diagnosis of amyloidosis'}, 'identificationModule': {'nctId': 'NCT03966105', 'briefTitle': 'Prevalence of Wild Type ATTR', 'organization': {'class': 'OTHER', 'fullName': 'Oncology Institute of Southern Switzerland'}, 'officialTitle': 'Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis', 'orgStudyIdInfo': {'id': 'IOSI-EMA-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with LSS surgery indication', 'interventionNames': ['Diagnostic Test: HE and Congo red staining']}], 'interventions': [{'name': 'HE and Congo red staining', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biopsies will be formalin fixed, processed routinely, and sent to the Department of Pathology for evaluation by hematoxylin and eosin and Congo red staining by pathologists. Biopsy specimens with confirmed amyloid deposits via Congo red staining will be further analyzed using immunohistochemistry for subtyping.', 'armGroupLabels': ['Patients with LSS surgery indication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500', 'city': 'Bellinzona', 'state': 'Canton Ticino', 'country': 'Switzerland', 'facility': 'Oncology Institute of Southern Switzerland', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}], 'overallOfficials': [{'name': 'Adalgisa Condoluci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oncology Institute of Southern Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oncology Institute of Southern Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kiel', 'class': 'OTHER'}, {'name': 'Ente Ospedaliero Cantonale, Bellinzona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Resident Physician', 'investigatorFullName': 'Adalgisa Condoluci', 'investigatorAffiliation': 'Oncology Institute of Southern Switzerland'}}}}