Actively Recruiting
Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
Led by Ospedale San Raffaele · Updated on 2024-05-16
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ospedale San Raffaele
Lead Sponsor
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying new biological markers to better understand the development and progression of Mycobacterium abscessus lung disease in patients with cystic fibrosis. The goal is to enhance knowledge of how this lung disease evolves by examining immune responses and inflammation related to the infection. This observational study involves several groups, including cystic fibrosis patients with chronic M. abscessus infection, those with M. abscessus pulmonary disease, patients without any history of M. abscessus infection, and healthy controls. Participants will undergo evaluations using advanced techniques such as Luminex and single-cell RNA sequencing (scRNAseq) to assess specific cell populations and circulating immune factors linked to the lung disease. The study aims to correlate early changes in immune cell profiles and markers with disease progression and clinical outcomes. These evaluations take place during normal clinical visits, following standard procedures at the participating centers. During the study, participants will have their immune cell populations and protein markers measured to track disease development and progression. The main outcome is to profile these cellular and molecular markers one month after enrollment. The study involves informed consent and includes patients aged 18 years and older. Researchers will monitor inflammatory responses and interactions between cellular and humoral immunity to support a deeper understanding of disease mechanisms.
CONDITIONS
Brief Title
Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of cystic fibrosis seen during standard clinical practice
- Both males and females
- Age over 18 years
- Provided informed consent according to study procedures
You will not qualify if you...
- Patients unable to understand study instructions and adequately accept the study methods
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 month after enrollment visit
Participants provide biological samples to evaluate specific cell populations and circulating factors related to immune responses associated with M. abscessus lung disease progression.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Ospedale San Raffaele
Milan, MI, Italy, 20132
Actively Recruiting
Research Team
N
Nicola I Lorè, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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