Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 6:37 AM
Study NCT ID:
NCT01916057
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D054019', 'term': 'Immune Reconstitution Inflammatory Syndrome'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2013-08-02', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global response to therapy', 'timeFrame': 'at month 3', 'description': 'Clinical assessment (no fever) and PET scan assessment (intensity of liver and/or spleen lesions)'}], 'secondaryOutcomes': [{'measure': '18F-FDG PET scan and RMI usefulness in initial diagnosis', 'timeFrame': 'at month 3', 'description': 'Comparison between Day 0 and Month 3 exams'}, {'measure': 'Serological and molecular mycological tools assessment', 'timeFrame': 'at day 0', 'description': 'Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls.\n\nAssessment of a new real-time PCR on serum and hepatic tissue'}, {'measure': 'Serological and molecular mycological tools assessment', 'timeFrame': 'at Month 3', 'description': 'Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls.\n\nAssessment of a new real-time PCR on serum and hepatic tissue'}, {'measure': 'Serological and molecular mycological tools assessment', 'timeFrame': 'at Month 6', 'description': 'Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls.\n\nAssessment of a new real-time PCR on serum and hepatic tissue'}, {'measure': 'Inflammatory cells and mediators', 'timeFrame': 'at day 0', 'description': 'Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls'}, {'measure': 'Inflammatory cells and mediators', 'timeFrame': 'at month 3', 'description': 'Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls'}, {'measure': 'Inflammatory cells and mediators', 'timeFrame': 'at month 6', 'description': 'Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls'}, {'measure': 'Genetic susceptibility', 'timeFrame': 'at day 0', 'description': 'Search for susceptibility genes to candidiasis in comparison with controls'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron-Emission Tomography Scan', 'Fluorodeoxyglucose F18', 'Magnetic Resonance Imaging', 'Enzyme-Linked Immunospot Assay', 'Immune Reconstitution Inflammatory Syndrome', 'Real-Time Polymerase Chain Reaction', 'beta-1,3-D-glucan', 'Candida spp.', 'Genetic Susceptibility', 'Genotype'], 'conditions': ['Invasive Fungal Disease', 'Chronic Disseminated Candidiasis', 'Hematological Malignancies', 'Hematopoietic Stem Cell Transplantation', 'Neutropenia']}, 'referencesModule': {'references': [{'pmid': '36606049', 'type': 'BACKGROUND', 'citation': 'Rammaert B, Maunoury C, Rabeony T, Correas JM, Elie C, Alfandari S, Berger P, Rubio MT, Braun T, Bakouboula P, Candon S, Montravers F, Lortholary O. Does 18F-FDG PET/CT add value to conventional imaging in clinical assessment of chronic disseminated candidiasis? Front Med (Lausanne). 2022 Dec 20;9:1026067. doi: 10.3389/fmed.2022.1026067. eCollection 2022.'}, {'pmid': '31879764', 'type': 'BACKGROUND', 'citation': 'Candon S, Rammaert B, Foray AP, Moreira B, Gallego Hernanz MP, Chatenoud L, Lortholary O. Chronic Disseminated Candidiasis During Hematological Malignancies: An Immune Reconstitution Inflammatory Syndrome With Expansion of Pathogen-Specific T Helper Type 1 Cells. J Infect Dis. 2020 May 11;221(11):1907-1916. doi: 10.1093/infdis/jiz688.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.', 'detailedDescription': 'Chronic disseminated candidiasis, often referred to as hepatosplenic candidiasis (HSC), is an infection due to Candida spp. that mainly involves the liver and spleen. HSC occurs mostly in patients with profound and prolonged neutropenia, which is more often seen in patients with hematologic malignancies. Despite an appropriate antifungal prophylaxis, the incidence of HSC in France might be closed to 5% in patients suffering from acute leukemia. Early and adequate diagnosis and treatment of HSC are crucial, as treatment delays can negatively affect the prognosis of the underlying condition. Current guidelines recommend a 6-month duration treatment. Prolonged treatments up to 6 months are frequent, leading to antifungal toxicity and cost increase. Preliminary study by our team has already assessed F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) as a diagnostic tool for HSC. 18F-FDG PET scan could be helpful in the diagnosis, follow-up and therapy strategy of HSC, helping to stop antifungal treatment. Other molecular, immunological and serological tools have to be developed in order to avoid hepatic biopsies. Actually, mycological evidence of infection is found in only 20% of the cases. The pathogenesis of HSC is also not well understood, but it is believed that it may be due to an unbalanced adaptive immune response that leads to an exacerbated inflammatory reaction, resulting in an Immune Reconstitution Inflammatory Syndrome (IRIS). In that context, a better understanding of the disease pathophysiology and of the potential genetic susceptibility could have an impact on therapy strategy. For example, new approaches such as the use of adjuvant high-dose corticosteroids have been shown beneficial. This study is the first step to improve HSC diagnosis and therapy strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Patients' inclusion criteria:\n\n* Adults aged ≥18 years-old\n* Hospitalized for hematological malignancy or hematopoietic stem cell transplantation\n* Recent (\\>2months), prolonged (\\>10 days), profound (\\>100 PMN/mm3), feverish neutropenia\n* Suspected hepatosplenic candidiasis (typical small nodular lesions on abdominal RMI or CT)\n\nPatients' exclusion criteria:\n\n\\- hepatosplenic lesions of other proven origin\n\nPatients' non-inclusion criteria:\n\n* Life expectancy \\>3 months\n* Pregnancy\n* HIV infection\n* Hepatic biopsy within 3 weeks before 18F-FDG PET scan"}, 'identificationModule': {'nctId': 'NCT01916057', 'acronym': 'CANHPARI', 'briefTitle': 'Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Multicenter Prospective Pilot Study Investigating Pathophysiology, Diagnostic and Therapeutic Strategies of Hepatosplenic Candidiasis', 'orgStudyIdInfo': {'id': 'P120115'}, 'secondaryIdInfos': [{'id': 'AOM12047'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-FDG PET Scan', 'description': '18F-FDG PET Scan at Day 0 and M3', 'interventionNames': ['Device: 18F-FDG PET Scan']}], 'interventions': [{'name': '18F-FDG PET Scan', 'type': 'DEVICE', 'description': 'to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.', 'armGroupLabels': ['18F-FDG PET Scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': "Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades,", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}