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

NCT ID: NCT06413459

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-08

Study Completion Date

2027-03-30

Brief Summary

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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

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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.

Conditions

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Non-Tuberculous Mycobacterial Pneumonia Cystic Fibrosis Lung

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CF patients with chronic M. abscessus infection

Luminex; scRNAsec

Intervention Type 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

Luminex; scRNAsec

Intervention Type OTHER

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

Luminex; scRNAsec

Intervention Type OTHER

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

Healty Controls

Luminex; scRNAsec

Intervention Type OTHER

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

Interventions

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Luminex; scRNAsec

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role collaborator

Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Nicola Lore

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale San Raffaele

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nicola I Lorè, PhD

Role: CONTACT

+390226434902

Facility Contacts

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Nicola I Lorè, PhD

Role: primary

+390226434902

Other Identifiers

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BioMol-MA

Identifier Type: -

Identifier Source: org_study_id

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