Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis

Recruiting

• Conditions: Non-Tuberculous Mycobacterial Pneumonia; Cystic Fibrosis Lung
• Interventions: Other: Luminex; scRNAsec

• Registration Number: NCT06413459
• Lead Sponsor: Ospedale San Raffaele

Brief Summary

In this project the investigators aim to identify new biological markers by characterizing the response/inflammation associated with the development and progression of M. abscessus lung disease in patients suffering from cystic fibrosis with the aim of increasing current knowledge available on the development and progression of lung disease.

Detailed Description

Main objective:

Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis.

Secondary objectives

* Identify cellular expression profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome

* Identify biomarkers or molecular profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome

* Expand pathogenetic knowledge to support disease progression pulmonary disease from M. abscessus in patients with cystic fibrosis and evaluate their ability to predict clinical outcome.

* Describe the reciprocal interactions between cellular and humoral components of the response inflammatory disease during M. abscessus infection with/without M. abscessus lung disease.

Study Timeline

• Study Start: 2021-04-08
• Status Verified: 2023-09
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-14
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2027-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with a certain diagnosis of cystic fibrosis and visited during normal clinical practice, in accordance with the standard operating procedures in force at the Centres.
• Both sexes
• Age >18 years
• Obtaining informed consent for patients (based on the procedures established by the protocol).

Exclusion Criteria

• Patients unable to understand the instructions and information provided and be able to adequately accept the study methods.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CF patients with M. abscessus pulmonary disease	Luminex; scRNAsec	-
CF patients with no history of M. abscessus infection	Luminex; scRNAsec	-
CF patients with chronic M. abscessus infection	Luminex; scRNAsec	-
Healty Controls	Luminex; scRNAsec	-

Primary Outcome Measures

Name	Time	Method
profile of specific cell populations and expression markers to determine the development and progression of M. abscessus lung disease in patients with CF	One month after enrollment visit	Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milan, MI, Italy