Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-28 @ 9:00 AM
Study NCT ID:
NCT05862961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-17
First Post:
2023-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Better Classification of Respiratory Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fixed tissue (Lung biopsy, Bronchial biopsy; trans-thoracic lung biopsy, trans-bronchial lung biopsy).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cases with identification of the amylogenic protein in respiratory amyloidosis.', 'timeFrame': '1 day (at inclusion)', 'description': 'Identification of amylogenic protein by Proteomic Analysis Based on Tandem Mass Spectrometry on histological sample of the tracheobronchial or pulmonary tree.'}], 'secondaryOutcomes': [{'measure': 'Distribution and severity of amyloidosis', 'timeFrame': '1 day (at inclusion)', 'description': 'association between typing and respiratory involvement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory amyloidosis', 'proteomic analysis'], 'conditions': ['Amyloidosis']}, 'descriptionModule': {'briefSummary': 'The B-AR project is based on a retrospective analysis of amyloidosis typing and the identification of their amylogenic protein.This work should be able to unite many clinicians, including pulmonologists and pathologists around a rare disease that still suffers from insufficient data.', 'detailedDescription': 'The B-AR study will highlight the interest of proteomic analysis of amyloidosis compared to their identification by immunostaining. The objective is to reduce diagnostic wandering and to improve patient management. The typing of respiratory amyloidosis will allow a better characterization of the disease and thus, to propose a dedicated therapeutic management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with respiratory amyloidosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient \\> to 18 years with amyloidosis on a histological sample of the tracheobronchial or pulmonary tree.\n\nExclusion Criteria:\n\n* Subject receiving state medical aid\n* Subject deprived of freedom, or under a legal protective measure (example: patients under guardianship or curators)'}, 'identificationModule': {'nctId': 'NCT05862961', 'acronym': 'B-AR', 'briefTitle': 'Better Classification of Respiratory Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Towards a Better Classification of Respiratory Amyloidosis. Contribution of Proteomic Analysis Based on Tandem Mass Spectrometry', 'orgStudyIdInfo': {'id': 'APHP220270'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yurdagül UZUNHAN, Pr,MD, PhD', 'role': 'CONTACT', 'email': 'yurdagul.uzunhan@aphp.fr', 'phone': '01 48 95 52 80'}, {'name': 'Magali COLOMBAT, MD PhD', 'role': 'CONTACT', 'email': 'Colombat.Magali@iuct-oncopole.fr'}], 'overallOfficials': [{'name': 'Yurdagül UZUNHAN, Pr,MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHP Hôpital Avicenne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}