Cystic Fibrosis Patient Clinical Trial
| NCT number | NCT02550041 |
| Other study ID # | UF 9582 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 7, 2015 |
| Est. completion date | June 2017 |
| Verified date | December 2016 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 68 |
| Est. completion date | June 2017 |
| Est. primary completion date | September 7, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Irmb/U1058 | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 12 months | |
| Primary | Cytokine level of TCD8 | Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis | 12 months | |
| Primary | Cytokine level CD4 cells | Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis | 12 months | |
| Secondary | Level of fumigatus specific IgE | Contribution of several biological tests improve classification of aspergillus bronchitis | 12 months | |
| Secondary | Level of fumigatus specific IgG | Contribution of several biological tests improve classification of aspergillus bronchitis | 12 months | |
| Secondary | Real-time PCR for aspergillus in sputum | Contribution of several biological tests improve classification of aspergillus bronchitis | 12 months | |
| Secondary | Galactomannan by enzyme immune assay detection in sputum | Contribution of several biological tests improve classification of aspergillus bronchitis | 12 months | |
| Secondary | Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry | Contribution of several biological tests improve classification of aspergillus bronchitis | 12 months | |
| Secondary | Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells | Contribution of several biological tests improve classification of aspergillus bronchitis | 12 months | |
| Secondary | Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment | 12 months | ||
| Secondary | Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells | Contribution of several biological tests improve classification of aspergillus bronchitis | 12 months | |
| Secondary | Elispot dedicated to anti-aspergillus CD4 T cell | 12 months |