Actively Recruiting
Cellular Markers During a Non-tuberculous Mycobacterial Respiratory Infection, Treated or Untreated, in Patients With Cystic Fibrosis
Led by University Hospital, Montpellier · Updated on 2025-07-10
76
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
H
Hôpital Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new diagnostic blood test for Non-Tuberculous Mycobacterial (NTM) infection in people with cystic fibrosis. This test measures the immune system's T cell response to the infection. The study aims to better understand how the body reacts to NTM in these patients by comparing those with and without infection. It is a multicenter case-control study focusing on T cell release of interferon-gamma as a marker of infection. The study involves one scheduled visit during routine cystic fibrosis care where a blood sample is taken. An additional 7 ml tube of blood will be collected to perform serology and culture tests. Patients are grouped based on positive or negative NTM serology and culture results. This approach allows researchers to assess cellular biomarkers linked to NTM infection. Participants will have their blood tested for the interferon-gamma release assay and T lymphocyte response during this single visit. The study measures the immune response to NTM antigens to provide more detailed diagnostic information than standard methods. The total participation involves just this one visit, which coincides with regular clinical care for cystic fibrosis.
CONDITIONS
Brief Title
Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years or older
- Previously included in the CIMeNT study
- Confirmed diagnosis of cystic fibrosis regardless of CFTR genotype
- Affiliated to the social security system
- Registered in the French Cystic Fibrosis Registry
- Adult capable of spontaneous expectoration or after induction
You will not qualify if you...
- Lung transplant patients
- Persons under judicial protection
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo a single scheduled visit as part of routine care where blood samples are taken to perform serology, culture, and measure cellular biomarkers to define infection status.
1 visit (in-person)
Duration - Ongoing
Participants who undergo routine care are observed based on the results from the diagnostic evaluation to assess the dynamics of non-tuberculous mycobacterial infection.
Routine cystic fibrosis care visits
Trial Site Locations
Total: 1 location
1
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
Actively Recruiting
Research Team
R
Raphael CHIRON, MD
J
Jean-Louis HERRMANN, Pr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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