Actively Recruiting

Age: 18Years +
All Genders
ID06413459

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Patients unable to understand study instructions and adequately accept the study methods

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Sample Collection

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

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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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