Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT06485895
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity of TB-IGRA 2nd generation test', 'timeFrame': '24 MONTHS'}, {'measure': 'specificity of TB-IGRA 2nd generation test', 'timeFrame': '24 MONTHS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TUBERCULOSIS']}, 'descriptionModule': {'briefSummary': 'Methodology This is a single-center study carried out as part of routine patient care.\n\nThe aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.', 'detailedDescription': 'It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individual at least 18 years of age\n* Patient presenting for treatment of tuberculosis disease\n* Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test.\n* Informed patient who has not expressed opposition to participating in the study.\n\nFrench-speaking patient with unambiguous understanding of oral and written instructions.\n\nExclusion Criteria:\n\nPersons in a period of exclusion from another study\n\n* Pregnant, parturient or breast-feeding women;\n* Person deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT06485895', 'acronym': 'TUBIGRA', 'briefTitle': 'Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis', 'orgStudyIdInfo': {'id': 'RCAPHM24_0100'}, 'secondaryIdInfos': [{'id': '2024-A00322-45', 'type': 'OTHER', 'domain': 'N°IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TUBERCULOSIS (LATENTE OR ACTIVE) ARM', 'interventionNames': ['Diagnostic Test: test IGRA', 'Diagnostic Test: TEST QUATIFERON TB Gold Plus']}], 'interventions': [{'name': 'test IGRA', 'type': 'DIAGNOSTIC_TEST', 'description': 'BLOOD SAMPLES', 'armGroupLabels': ['TUBERCULOSIS (LATENTE OR ACTIVE) ARM']}, {'name': 'TEST QUATIFERON TB Gold Plus', 'type': 'DIAGNOSTIC_TEST', 'description': 'BLOOD SAMPLES', 'armGroupLabels': ['TUBERCULOSIS (LATENTE OR ACTIVE) ARM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ALEXANDRA GIULIANI', 'role': 'CONTACT', 'email': 'alexandra.giuliani@ap-hm.fr'}, {'name': 'PIERRE-EDOUARD FOURNIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'PR PIERRE EDOUARD FOURNIER PU-PH', 'role': 'CONTACT', 'email': 'pierre-edouard.fournier@ap-hm.fr', 'phone': '33+ 04 13 73 24 31'}, {'name': 'ALEXANDRA GIULIANI PROJECT MANAGER', 'role': 'CONTACT', 'email': 'alexandra.giuliani@ap-hm.fr'}], 'overallOfficials': [{'name': 'François CREMIEUX', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}