Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT02823132
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2016-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-07-05', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia', 'timeFrame': '1st day of the period of aplasia'}], 'secondaryOutcomes': [{'measure': 'Serum levels of MBL during an episode of aplasia for both groups of patients studied', 'timeFrame': 'Every day except Saturday and Sunday for roughly 3 weeks'}]}, 'conditionsModule': {'conditions': ['Acute Leukemia', 'Invasive Fungal Infection']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with acute leukemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* persons who have provided written consent\n* Patients with national health insurance cover\n* Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN \\< 500 / mm3) lasting more than 10 days.\n* Patients with malignant hemopathy who have received an autologous bone marrow graft\n* Patients with severe idiopathic medullar aplasia (PN \\< 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants)\n\nExclusion Criteria:\n\n* Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study).\n* Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days).\n* Patients whose neutropenia, retrospectively assessed, lasted less than 10 days.'}, 'identificationModule': {'nctId': 'NCT02823132', 'acronym': 'MBL INFFONG', 'briefTitle': 'Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)', 'orgStudyIdInfo': {'id': 'Goyer APJ 2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients who develop a fungal infection', 'interventionNames': ['Biological: blood sample']}, {'label': 'patients without fungal infection', 'interventionNames': ['Biological: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', 'armGroupLabels': ['patients who develop a fungal infection', 'patients without fungal infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}