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

Non-Tuberculous Mycobacterial Pneumonia Clinical Trial

— BioMol-MA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06413459
• Other study ID #: BioMol-MA
• Status: Recruiting
• Start date: April 8, 2021
• Est. completion date: March 30, 2027

Study information

• Verified date: September 2023
• Source: Ospedale San Raffaele
• Contact: Nicola I Lorè, PhD
• Phone: +390226434902
• Email: lore.nicolaivan[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis Lung
• Fibrosis
• Lung Diseases
• Non-Tuberculous Mycobacterial Pneumonia
• Pulmonary Fibrosis

Intervention

Other:
• Luminex; scRNAsec
Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan	MI

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale San Raffaele	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	profile of specific cell populations and expression markers to determine the development and progression of M. abscessus lung disease in patients with CF	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	One month after enrollment visit