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

Primary Purpose

Cystic Fibrosis Patient, Patient Without Treatment Against A.Fumigatus

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
T specific response for diagnostic of aspergillus bronchitis
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis Patient focused on measuring Bronchitis aspergillus, cystic fibrosis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irmb/U1058

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cystic fibrosis

Arm Description

Outcomes

Primary Outcome Measures

Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis
Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients
Cytokine level of TCD8
Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis
Cytokine level CD4 cells
Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis

Secondary Outcome Measures

Level of fumigatus specific IgE
Contribution of several biological tests improve classification of aspergillus bronchitis
Level of fumigatus specific IgG
Contribution of several biological tests improve classification of aspergillus bronchitis
Real-time PCR for aspergillus in sputum
Contribution of several biological tests improve classification of aspergillus bronchitis
Galactomannan by enzyme immune assay detection in sputum
Contribution of several biological tests improve classification of aspergillus bronchitis
Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry
Contribution of several biological tests improve classification of aspergillus bronchitis
Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Contribution of several biological tests improve classification of aspergillus bronchitis
Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment
Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Contribution of several biological tests improve classification of aspergillus bronchitis
Elispot dedicated to anti-aspergillus CD4 T cell

Full Information

First Posted
August 20, 2015
Last Updated
May 7, 2019
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02550041
Brief Title
Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulties for inclusions
Study Start Date
September 7, 2015 (Actual)
Primary Completion Date
September 7, 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis Patient, Patient Without Treatment Against A.Fumigatus
Keywords
Bronchitis aspergillus, cystic fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cystic fibrosis
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
T specific response for diagnostic of aspergillus bronchitis
Primary Outcome Measure Information:
Title
Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis
Description
Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients
Time Frame
12 months
Title
Cytokine level of TCD8
Description
Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis
Time Frame
12 months
Title
Cytokine level CD4 cells
Description
Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Level of fumigatus specific IgE
Description
Contribution of several biological tests improve classification of aspergillus bronchitis
Time Frame
12 months
Title
Level of fumigatus specific IgG
Description
Contribution of several biological tests improve classification of aspergillus bronchitis
Time Frame
12 months
Title
Real-time PCR for aspergillus in sputum
Description
Contribution of several biological tests improve classification of aspergillus bronchitis
Time Frame
12 months
Title
Galactomannan by enzyme immune assay detection in sputum
Description
Contribution of several biological tests improve classification of aspergillus bronchitis
Time Frame
12 months
Title
Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry
Description
Contribution of several biological tests improve classification of aspergillus bronchitis
Time Frame
12 months
Title
Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Description
Contribution of several biological tests improve classification of aspergillus bronchitis
Time Frame
12 months
Title
Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment
Time Frame
12 months
Title
Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Description
Contribution of several biological tests improve classification of aspergillus bronchitis
Time Frame
12 months
Title
Elispot dedicated to anti-aspergillus CD4 T cell
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Irmb/U1058
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

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

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