Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis

NCT06602869 | Recruiting

• 1 other identifier: RECHMPL24_0124
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Tuberculous Mycobacterial Pneumonia

Keywords

Cystic Fibrosis; Interferon gamma release assay; Diagnostic Test

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1 (V1)

Secondary Outcomes (1)

• Evaluation of T lymphocyte response

  day 1 (V1)

Study Arms (2)

Case group MNT +

Cystic fibrosis patients with positive serology and positive culture

Other: Scheduled visit (V1)

Control group MNT -

Cystic fibrosis patients with negative serology and negative culture

Other: Scheduled visit (V1)

Interventions

Scheduled visit (V1) OTHER

During 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.

Case group MNT +; Control group MNT -

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cystic fibrosis included in the CIMeNT study (N°ID RCB : 2017-A00025-48)

You may qualify if:

• 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

You may not qualify if:

• Lung transplant patients
• Person placed under judicial protection
• Pregnant and breastfeeding women

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Hôpital Cochin: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

myotrophin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Raphael CHIRON, MD

  Hôpital Arnaud de Villeneuve

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael CHIRON, MD

CONTACT

0467336115; r-chiron@chu-montpellier.fr

Jean-Louis HERRMANN, Pr

CONTACT

0147104470; jean-louis.herrmann@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 17, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

FR (1)