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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Tuberculous Mycobacterial Pneumonia; Cystic Fibrosis Lung
• Intervention / Treatment: Other: Luminex; scRNAsec

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Nicola I Lorè, PhD; Phone Number: +390226434902; Email: lore.nicolaivan@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Recruiting
      • Ospedale San Raffaele
      • Contact: Nicola I Lorè, PhD; Phone Number: +390226434902; Email: nicolaivanlore@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with cystic fibrosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CF patients with chronic M. abscessus infection	Other: Luminex; scRNAsec; Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses
CF patients with M. abscessus pulmonary disease	Other: Luminex; scRNAsec; Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses
CF patients with no history of M. abscessus infection	Other: Luminex; scRNAsec; Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses
Healty Controls	Other: Luminex; scRNAsec; Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ospedale San Raffaele
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: scRNASec
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Lung Diseases, Interstitial; Fibrosis; Lung Diseases; Pulmonary Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: BioMol-MA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No