Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-01 @ 5:13 AM
Study NCT ID:
NCT05750706
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2023-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of invasive fungal infections', 'timeFrame': '18 months', 'description': 'Incidence of invasive fungal infections during first week of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '30 months', 'description': 'Mortality rate among patients with invasive fungal infections'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia, Adult', 'Invasive Fungal Infections']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with B or T acute lymphoblastic leukemia Ph negative', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of acute lymphoblastic leukemia Ph negative\n* age more than 18 yo\n\nExclusion Criteria:\n\n* diagnosis of acute lymphoblastic leukemia Ph positive\n* acute lymphoblastic leukemia relapsed/refractory\n* lymphoblastic lymphoma'}, 'identificationModule': {'nctId': 'NCT05750706', 'acronym': 'SEIFEM', 'briefTitle': 'Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative', 'orgStudyIdInfo': {'id': '4976'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without invasive fungal infection', 'description': 'Acute lymphoblastic leukemia, no invasive fungal infection'}, {'label': 'Patients with invasive fungal infection', 'description': 'Acute lymphoblastic leukemia, invasive fungal infection', 'interventionNames': ['Other: observation of invasive fungal infections']}], 'interventions': [{'name': 'observation of invasive fungal infections', 'type': 'OTHER', 'description': 'observation of invasive fungal infections during chemotherapy', 'armGroupLabels': ['Patients with invasive fungal infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marianna Criscuolo', 'role': 'CONTACT', 'phone': '+390630154278'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Chiara Cattaneo', 'role': 'CONTACT', 'email': 'chiara.cattaneo@asst-spedalicivili.it', 'phone': '+390303996573'}], 'overallOfficials': [{'name': 'Marianna Criscuolo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asst Degli Spedali Civili Di Brescia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}