Trial record 12 of 41 for:    Open Studies | "Candidiasis"

Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis (CANHPARI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
CHUV, Lausanne, Switzerland
CHU, Lille, France
Institut Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01916057
First received: August 2, 2013
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Invasive Fungal Disease
Chronic Disseminated Candidiasis
Hematological Malignancies
Hematopoietic Stem Cell Transplantation
Neutropenia
Device: 18F-FDG PET Scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multicenter Prospective Pilot Study Investigating Pathophysiology, Diagnostic and Therapeutic Strategies of Hepatosplenic Candidiasis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Global response to therapy [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    Clinical assessment (no fever) and PET scan assessment (intensity of liver and/or spleen lesions)


Secondary Outcome Measures:
  • 18F-FDG PET scan and RMI usefulness in initial diagnosis [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    Comparison between Day 0 and Month 3 exams

  • Serological and molecular mycological tools assessment [ Time Frame: at day 0 ] [ Designated as safety issue: No ]

    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


  • Serological and molecular mycological tools assessment [ Time Frame: at Month 3 ] [ Designated as safety issue: No ]

    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


  • Serological and molecular mycological tools assessment [ Time Frame: at Month 6 ] [ Designated as safety issue: No ]

    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


  • Inflammatory cells and mediators [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
    Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls

  • Inflammatory cells and mediators [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls

  • Inflammatory cells and mediators [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls

  • Genetic susceptibility [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
    Search for susceptibility genes to candidiasis in comparison with controls


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 18F-FDG PET Scan
18F-FDG PET Scan at Day 0 and M3
Device: 18F-FDG PET Scan
to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Patients' inclusion criteria:

  • Adults aged ≥18 years-old
  • Hospitalized for hematological malignancy or hematopoietic stem cell transplantation
  • Recent (>2months), prolonged (>10 days), profound (>100 PMN/mm3), feverish neutropenia
  • Suspected hepatosplenic candidiasis (typical small nodular lesions on abdominal RMI or CT)

Patients' exclusion criteria:

- hepatosplenic lesions of other proven origin

Patients' non-inclusion criteria:

  • Life expectancy >3 months
  • Pregnancy
  • HIV infection
  • Hepatic biopsy within 3 weeks before 18F-FDG PET scan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916057

Contacts
Contact: Prissile BAKOUBOULA, PhD +33 1 58 41 34 78 canhpari.phrc@nck.aphp.fr
Contact: Laurence Lecomte, PhD +33158413545 laurence.lecomte@cch.aphp.fr

Locations
France
Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades, Recruiting
Paris, France, 75015
Contact: Prissile BAKOUBOULA, PhD    +33 1 58 41 34 78    canhpari.phrc@nck.aphp.fr   
Contact: Laurence lecomte, PhD    +33 1 58413545    Laurence.lecomte@cch.aphp.fr   
Principal Investigator: Blandine RAMMAERT, MD,         
Sub-Investigator: Oliier LORTHOLARY, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
CHUV, Lausanne, Switzerland
CHU, Lille, France
Institut Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01916057     History of Changes
Other Study ID Numbers: P120115, AOM12047
Study First Received: August 2, 2013
Last Updated: June 13, 2014
Health Authority: Ministry of Health : France

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
Candidiasis
Neoplasms
Mycoses
Neutropenia
Hematologic Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Neoplasms by Site
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014