We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis (CANHPARI)

This study is currently recruiting participants.
Verified July 2017 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01916057
First Posted: August 5, 2013
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Lausanne Hospitals
University Hospital, Lille
Institut Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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: None (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 ]
    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 ]
    Comparison between Day 0 and Month 3 exams

  • Serological and molecular mycological tools assessment [ Time Frame: at day 0 ]

    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 ]

    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 ]

    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 ]
    Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls

  • Inflammatory cells and mediators [ Time Frame: at month 3 ]
    Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls

  • Inflammatory cells and mediators [ Time Frame: at month 6 ]
    Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls

  • Genetic susceptibility [ Time Frame: at day 0 ]
    Search for susceptibility genes to candidiasis in comparison with controls


Estimated Enrollment: 100
Actual Study Start Date: November 19, 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916057


Contacts
Contact: Blandine RAMMAERT, MD, PhD +33 5 49 44 44 22 brammaert@yahoo.fr
Contact: Prissile Bakouboula, PhD +331 71 19 64 94 prissile.bakouboula@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 71 19 64 94    canhpari.phrc@nck.aphp.fr   
Principal Investigator: Blandine RAMMAERT, MD,         
Sub-Investigator: Olivier LORTHOLARY, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
University of Lausanne Hospitals
University Hospital, Lille
Institut Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01916057     History of Changes
Other Study ID Numbers: P120115
AOM12047
First Submitted: August 2, 2013
First Posted: August 5, 2013
Last Update Posted: August 1, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Neutropenia
Mycoses
Invasive Fungal Infections
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action