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Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients

This study has been terminated.
(Difficulties for inclusions)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02550041
First Posted: September 15, 2015
Last Update Posted: December 23, 2016
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. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose

The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.

In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.


Condition Intervention
Cystic Fibrosis Patient Patient Without Treatment Against A.Fumigatus Other: T specific response for diagnostic of aspergillus bronchitis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis [ Time Frame: 12 months ]
    Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients

  • Cytokine level of TCD8 [ Time Frame: 12 months ]
    Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis

  • Cytokine level CD4 cells [ Time Frame: 12 months ]
    Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis


Secondary Outcome Measures:
  • Level of fumigatus specific IgE [ Time Frame: 12 months ]
    Contribution of several biological tests improve classification of aspergillus bronchitis

  • Level of fumigatus specific IgG [ Time Frame: 12 months ]
    Contribution of several biological tests improve classification of aspergillus bronchitis

  • Real-time PCR for aspergillus in sputum [ Time Frame: 12 months ]
    Contribution of several biological tests improve classification of aspergillus bronchitis

  • Galactomannan by enzyme immune assay detection in sputum [ Time Frame: 12 months ]
    Contribution of several biological tests improve classification of aspergillus bronchitis

  • Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry [ Time Frame: 12 months ]
    Contribution of several biological tests improve classification of aspergillus bronchitis

  • Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells [ Time Frame: 12 months ]
    Contribution of several biological tests improve classification of aspergillus bronchitis

  • Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment [ Time Frame: 12 months ]
  • Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells [ Time Frame: 12 months ]
    Contribution of several biological tests improve classification of aspergillus bronchitis

  • Elispot dedicated to anti-aspergillus CD4 T cell [ Time Frame: 12 months ]

Enrollment: 68
Study Start Date: August 2015
Estimated Study Completion Date: June 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cystic fibrosis Other: T specific response for diagnostic of aspergillus bronchitis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier
  • Patient aged 15 or over
  • Patient able to understand the nature, purpose and methodology of the study.
  • Patient and his legal representative for minors who have given their free and informed consent
  • Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

  • Patients on antifungal treatment at the time of sampling
  • Pregnant or breastfeeding
  • Major protected by law (guardianship, curator or under Backup Justice)
  • Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
  • Subject attending another search including a period of exclusion still going to run-in
  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): NCT02550041


Locations
France
Irmb/U1058
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02550041     History of Changes
Other Study ID Numbers: UF 9582
First Submitted: August 20, 2015
First Posted: September 15, 2015
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by University Hospital, Montpellier:
Bronchitis aspergillus
cystic fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Bronchitis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections