Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602869
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cellular Markers During a Non-tuberculous Mycobacterial Respiratory Infection Treated or Untreated in Patients With Cystic Fibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUCEM
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 pathogens presence This multicenter case-control study involves two populations providing a better understanding of the circulating T-IFNγ-MNT response in these patients
Detailed Description:
Background Evidence shows that Non-tuberculous Mycobacterial NTM infections have increased and are 1000 to 8000 times more frequent in patients with cystic fibrosis compared to the general population The diagnosis is based on clinical radiological and microbiological criteria Unfortunately the first two criteria lack specificity and microbiological detection of NTM is limited due to frequent sputum contamination by other pathogens in cystic fibrosis patients Given these factors and the high incidence of NTM infections in this population alternative diagnostic methods are necessary
Aim This study aims to validate an innovative diagnostic test based on the IGRA Interferon-Gamma Release Assay method which measures T lymphocyte response to Interferon gamma IFNγ The test will be conducted on a subset of patients selected from the CIMeNT cohort ID-RCB 2017-A00025-48 This cohort consists of cystic fibrosis patients whose NTM infection prevalence has been previously assessed
Method This research is a multicenter case-control study It includes two groups a case group of patients with positive serological andor microbiological responses indicating NTM infection and a control group of patients without such responses The test measures the hosts immune response by evaluating circulating T cell activity Specifically it measures IFNγ release when T cells are in contact with NTM antigens This method provides more informative diagnostics of NTM infection dynamics compared to serology or microbiology which have known technical limitations
The study involves a single visit which is part of the routine care for cystic fibrosis patients During this visit a routine blood draw will be performed and an additional 7 ml tube will be collected
Aim This study aims to validate an innovative diagnostic test based on the IGRA Interferon-Gamma Release Assay method which measures T lymphocyte response to Interferon gamma IFNγ The test will be conducted on a subset of patients selected from the CIMeNT cohort ID-RCB 2017-A00025-48 This cohort consists of cystic fibrosis patients whose NTM infection prevalence has been previously assessed
Method This research is a multicenter case-control study It includes two groups a case group of patients with positive serological andor microbiological responses indicating NTM infection and a control group of patients without such responses The test measures the hosts immune response by evaluating circulating T cell activity Specifically it measures IFNγ release when T cells are in contact with NTM antigens This method provides more informative diagnostics of NTM infection dynamics compared to serology or microbiology which have known technical limitations
The study involves a single visit which is part of the routine care for cystic fibrosis patients During this visit a routine blood draw will be performed and an additional 7 ml tube will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None