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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06413459
Acronym
BioMol-MA
Enrollment
40
Registered
2024-05-14
Start date
2021-04-08
Completion date
2027-03-30
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis Lung, Non-Tuberculous Mycobacterial Pneumonia

Keywords

scRNASec

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.

Interventions

OTHERLuminex; scRNAsec

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

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
Ospedale San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
profile of specific cell populations and expression markers to determine the development and progression of M. abscessus lung disease in patients with CFOne month after enrollment visitEvaluate 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

Countries

Italy

Contacts

Primary ContactNicola I Lorè, PhD
lore.nicolaivan@hsr.it+390226434902

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026