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

San Donato Group (GSD)

Status: Enrolling

Conditions: Non-Tuberculous Mycobacterial Pneumonia; Cystic Fibrosis Lung

Treatments: Other: Luminex; scRNAsec

Study type: Observational

Funder types: Other

Identifiers

NCT06413459

BioMol-MA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 4 patient groups

CF patients with chronic M. abscessus infection

Treatment:

Other: Luminex; scRNAsec

CF patients with M. abscessus pulmonary disease

Treatment:

Other: Luminex; scRNAsec

CF patients with no history of M. abscessus infection

Treatment:

Other: Luminex; scRNAsec

Healty Controls

Treatment:

Other: Luminex; scRNAsec