Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-28 @ 6:50 AM
Study NCT ID:
NCT06185166
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
State of Play of Non-tuberculous Mycobacteria in Alsace
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective description of non-tuberculous mycobacteria in Alsace', 'timeFrame': 'Through study completion, an average of 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Tuberculous Mycobacteria'], 'conditions': ['Non-Tuberculous Mycobacteria']}, 'descriptionModule': {'briefSummary': 'Non-tuberculous mycobacteriosis (NTM) are infectious diseases caused by mycobacteria that are not part of the Tuberculosis complex. More than 190 species have been identified to date.\n\nAs an environmental reservoir, it most often affects the lungs, skin and soft tissues, lymph nodes, but it can affect all organs. Varying in virulence depending on the species, most infections do not cause illness.\n\nThere is currently no coordinated care pathway for this pathology in Alsace. The means necessary to set up such a structure requires knowing the importance of the disease.', 'detailedDescription': 'The aim of the study is to determine the incidence of non-tuberculous mycobacterial infections in the ALSACE region, the proportion of cases in which the infection causes illness, and its evolution over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subject (≥ 18 years old) in whom a biological sample is culture positive for a non-tuberculous mycobacterium', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subject (≥ 18 years old)\n* in whom a biological sample is culture positive for a non-tuberculous mycobacterium\n* born in France and domiciled in Alsace (i.e. whose home postal code begins with 67 or 68)\n* not opposing the reuse of its data for scientific research purposes\n\nExclusion Criteria:\n\n* Subject having expressed opposition to participating in the study\n* not domiciled in Alsace\n* Born abroad\n* Isolation of a mycobacterium from the Tuberculosis complex and Mycobacterium gordonae'}, 'identificationModule': {'nctId': 'NCT06185166', 'acronym': 'Mycoba', 'briefTitle': 'State of Play of Non-tuberculous Mycobacteria in Alsace', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'State of Play of Non-tuberculous Mycobacteria in Alsace: a Retrospective Study', 'orgStudyIdInfo': {'id': '8780'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Loïc KASSEGNE, MD', 'role': 'CONTACT', 'email': 'loic.kassegne@chru-strasbourg.fr', 'phone': '33 3 69 55 01 88'}, {'name': 'Loïc KASSEGNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Pneumologie - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Loïc KASSEGNE, MD', 'role': 'CONTACT', 'email': 'loic.kassegne@chru-strasbourg.fr', 'phone': '33 3 69 55 01 88'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}