Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Non-Tuberculous Mycobacterial Pneumonia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment76 (estimated)
SponsorUniversity Hospital, Montpellier
Academic / other
Locations1 site (Montpellier)
StatusRecruiting
StartedSeptember 17, 2024
Main results expectedAugust 1, 2026
Study endsSeptember 17, 2026
Registry record updatedJuly 10, 2025
Trial IDNCT06602869 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

  • CHU de Montpellier - Hôpital Arnaud de Villeneuve
    Montpellier, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.