Cellular markers for non-tuberculous mycobacterial infection in adults with cystic fibrosis
Official title: Cellular Markers During a Non-tuberculous Mycobacterial Respiratory Infection, Treated or Untreated, in Patients With Cystic Fibrosis
Run by University Hospital, Montpellier · NCT06602869 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Status | Recruiting |
| Started | September 17, 2024 |
| Main results expected | August 1, 2026 |
| Study ends | September 17, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT06602869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Registry to collect data on mycobacterial infections in Austria
This study is collecting information from patients in Austria with mycobacterial infections to see how their treatment goes and what factors might affect their recovery.
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Identifying new biological markers for lung disease in cystic fibrosis patients
This study is trying to find new biological markers in cystic fibrosis patients to better understand and track lung disease caused by Mycobacterium abscessus.
-
Creating a database for patients with bronchiectasis and NTM in Canada
This study is creating a database to gather information from adults with bronchiectasis and NTM to help improve care and understanding of these conditions.
-
Using a daily symptom diary to monitor NTM lung infections
This project will test whether a daily symptom diary can track disease course in adults with pulmonary nontuberculous mycobacterial (NTM) infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.