Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:41 PM
Study NCT ID:
NCT07485868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Clinical-epidemiological Score Predictive of Tuberculosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D048788', 'term': 'Growth and Development'}], 'ancestors': [{'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 686}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'construction of a logistic regression model', 'timeFrame': '5 years', 'description': 'construction of a logistic regression model based on clinical and epidemiological variables significantly associated with pulmonary tuberculosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': "Despite being a curable and preventable disease, tuberculosis still represents a major global health problem. It is estimated that 10.8 million people contracted tuberculosis in 2023, with an incidence of 134 per 100,000 inhabitants. In 2023, there were 1.25 million deaths, confirming this disease as a leading cause of death and the leading cause of death from a single infectious agent. It is a disease that primarily affects adults in their most productive years, with significant repercussions on family budgets. The aim of this study is to identify and characterize the demographic, epidemiological, microbiological, clinical, and radiological variables of the tuberculosis population that has come to our hospital's attention, as an exemplary population in a low-endemic setting. This study also aims to develop a tuberculosis risk score aimed at early differentiation between patients requiring respiratory isolation and those with negligible tuberculosis risk, and to improve diagnostic accuracy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with clinically suspected tuberculosis Infectious disease specialists and emergency room physicians', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* atients aged ≥18 years;\n* Patients hospitalized during the study period who, due to a clinical suspicion of tuberculosis, underwent diagnostic tests on respiratory samples (sputum, induced sputum, tracheal aspirate, bronchoalveolar lavage) at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS.\n* Informed consent will be obtained for prospective patients, while for retrospective patients, reference will be made to Article 110-bis of the Privacy Code.\n\nExclusion Criteria:\n\n* Patients \\<18 years of age;\n* Patient already included (each patient will be included only once, regardless of the number of isolations).'}, 'identificationModule': {'nctId': 'NCT07485868', 'acronym': 'SCORE-TB', 'briefTitle': 'Development of a Clinical-epidemiological Score Predictive of Tuberculosis.', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Creation of a Cohort of Patients With Tuberculosis or Suspected Tuberculosis Admitted to a University Hospital in a Low-endemic Setting, Development of a Clinical-epidemiological Score Predictive of Tuberculosis, Optimization of the Diagnostic-therapeutic Pathway.', 'orgStudyIdInfo': {'id': '15560'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis', 'type': 'OTHER', 'description': 'Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis. External validation through surveys on clinicians'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Antonella Cingolani, Dr', 'role': 'CONTACT', 'email': 'antonella.cingolani@policlinicogemelli.it', 'phone': '00390630154945'}, {'name': 'Paola Del Giacomo, Dr', 'role': 'CONTACT', 'email': 'paola.delgiacomo@policlinicogemelli.it', 'phone': '00390630154945'}], 'overallOfficials': [{'name': 'Antonella Cingolani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}