Cellular markers for non-tuberculous mycobacterial infection in adults with cystic fibrosis
Cellular Markers During a Non-tuberculous Mycobacterial Respiratory Infection, Treated or Untreated, in Patients With Cystic Fibrosis
This test will try a blood-based IGRA that measures T-cell interferon-gamma response to help detect NTM infection in adults with cystic fibrosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06602869 on ClinicalTrials.gov |
What this trial studies
This multicenter case-control study uses an Interferon-Gamma Release Assay (IGRA) to measure circulating T-cell IFNγ responses to NTM antigens in adults with cystic fibrosis drawn from the CIMeNT cohort. Participants are grouped as cases with positive serologic or microbiologic evidence of NTM and controls without such evidence, and blood samples are collected during a scheduled visit. The study aims to characterize a dynamic immune signature associated with NTM presence that could complement current clinical, radiological, and microbiological criteria. Sites include CHU de Montpellier and Hôpital Cochin, with coordination by the University Hospital Montpellier and collaborators including the Cystic Fibrosis Foundation.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed diagnosis of cystic fibrosis who were previously enrolled in the CIMeNT cohort, are registered in the French Cystic Fibrosis Registry, and can provide spontaneous or induced sputum are ideal candidates.
Not a fit: Lung transplant recipients, pregnant or breastfeeding individuals, people not enrolled in the CIMeNT cohort, or those unable to produce sputum would not be eligible and are unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, this blood-based immune test could offer a faster, less contamination-prone tool to improve detection of NTM infections in people with cystic fibrosis and help guide treatment decisions.
How similar studies have performed: Related T-cell IGRA approaches for mycobacterial infections have shown promise in pilot studies but are not yet established as routine diagnostics for NTM, so this validation aims to add important supporting data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Patient registered in the French Cystic Fibrosis Registry * Adult patient capable of spontaneous expectoration or after induction Exclusion Criteria: * Lung transplant patients * Person placed under judicial protection * Pregnant and breastfeeding women
Where this trial is running
Montpellier
- CHU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Raphael CHIRON, MD — Hôpital Arnaud de Villeneuve
- Study coordinator: Raphael CHIRON, MD
- Email: r-chiron@chu-montpellier.fr
- Phone: 0467336115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.