Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Cystic fibrosis
干预措施: T specific response for diagnostic of aspergillus bronchitis (Other)
结局指标
主要结局
Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis
时间窗: 12 months
Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients
Cytokine level CD4 cells
时间窗: 12 months
Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis
Cytokine level of TCD8
时间窗: 12 months
Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis
次要结局
- Level of fumigatus specific IgE(12 months)
- Level of fumigatus specific IgG(12 months)
- Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells(12 months)
- Real-time PCR for aspergillus in sputum(12 months)
- Galactomannan by enzyme immune assay detection in sputum(12 months)
- Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry(12 months)
- Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells(12 months)
- Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment(12 months)
- Elispot dedicated to anti-aspergillus CD4 T cell(12 months)