This study evaluates a diagnostic serological test for Non-Tuberculous Mycobacteria (NTM) infection in cystic fibrosis patients by measuring T cell response. It aims to highlight a dynamic response associated to the pathogen's presence. This multicenter case-control study involves two populations, providing a better understanding of the circulating T-IFNγ-MNT response in these patients.
Patient ≥18 years
Patient previously included in the CIMeNT study
Patient with a confirmed diagnosis of cystic fibrosis regardless of CFTR genotype
Patient affiliated to the social security system
Lung transplant patients
Person placed under judicial protection
Pregnant and breastfeeding women
Adult patients with cystic fibrosis included in the CIMeNT study (N°ID RCB : 2017-A00025-48)
Case-control
Cross-sectional
Scheduled visit (V1)
Other interventionDuring the scheduled visit (V1), as part of routine care, a blood draw will be performed. On this occasion, an additional 7 ml tube will be collected to perform serology and culture. This will help define the group (NTM+ Cases/NTM- Controls) and measure cellular biomarkers.
Determination of interferon-gamma release assay
Evaluation of T lymphocyte activation following mycobacterial antigen stimulation. The level of interferon gamma (IFN-γ) released is the measured marker of this activation, quantified in IU/ml. Sensitivity and specificity pairs will be calculated for each threshold value of the IFNγ rate in the T cell response test. A Receiver Operating Characteristic (ROC) curve will be plotted with its Area Under the Curve (AUC) and 95% confidence interval. For each threshold, sensitivity and specificity values will be computed, along with their 95% confidence intervals. The assessment aims to diagnose NTM in patients, as confirmed by serology and/or positive culture.
Evaluation of T lymphocyte response
Measurement of IFN-γ release in response to T cell contact with NTM antigens, compared to clinical and radiological progression.
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University Hospital, Montpellier
Lead sponsor
Hôpital Cochin
Collaborator
Cystic Fibrosis Foundation
Collaborator
