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| ID | Type | Description | Link |
|---|---|---|---|
| AOM12047 |
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| Name | Class |
|---|---|
| University of Lausanne Hospitals | OTHER |
| University Hospital, Lille | OTHER |
| Institut Pasteur | INDUSTRY |
| Institut National de la Santé Et de la Recherche Médicale, France |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FDG PET Scan | Experimental | 18F-FDG PET Scan at Day 0 and M3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG PET Scan | Device | to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Global response to therapy | Clinical assessment (no fever) and PET scan assessment (intensity of liver and/or spleen lesions) | at month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 18F-FDG PET scan and RMI usefulness in initial diagnosis | Comparison between Day 0 and Month 3 exams | at month 3 |
| Serological and molecular mycological tools assessment | Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls. Assessment of a new real-time PCR on serum and hepatic tissue |
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Patients' inclusion criteria:
Patients' exclusion criteria:
- hepatosplenic lesions of other proven origin
Patients' non-inclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades, | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36606049 | Result | 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. | |
| 31879764 |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D019337 | Hematologic Neoplasms |
| D009503 | Neutropenia |
| D054019 | Immune Reconstitution Inflammatory Syndrome |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009371 | Neoplasms by Site |
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| OTHER_GOV |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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| at day 0 |
| Serological and molecular mycological tools assessment | Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls. Assessment of a new real-time PCR on serum and hepatic tissue | at Month 3 |
| Serological and molecular mycological tools assessment | Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls. Assessment of a new real-time PCR on serum and hepatic tissue | at Month 6 |
| Inflammatory cells and mediators | Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls | at day 0 |
| Inflammatory cells and mediators | Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls | at month 3 |
| Inflammatory cells and mediators | Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls | at month 6 |
| Genetic susceptibility | Search for susceptibility genes to candidiasis in comparison with controls | at day 0 |
| 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. |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D007154 | Immune System Diseases |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |