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

NCT06413459 | Recruiting

• 1 other identifier: BioMol-MA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Tuberculous Mycobacterial Pneumonia; Cystic Fibrosis Lung

Keywords

scRNASec

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

CF patients with chronic M. abscessus infection

Other: Luminex; scRNAsec

CF patients with M. abscessus pulmonary disease

Other: Luminex; scRNAsec

CF patients with no history of M. abscessus infection

Other: Luminex; scRNAsec

Healty Controls

Other: Luminex; scRNAsec

Interventions

Luminex; scRNAsec OTHER

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; CF patients with chronic M. abscessus infection; CF patients with no history of M. abscessus infection; Healty Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cystic fibrosis

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Raffaele: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

PBMCs and Plasma

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Nicola I Lorè, PhD

CONTACT

+390226434902; lore.nicolaivan@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: April 8, 2021
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 16, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)