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
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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RECRUITING
40 participants
OBSERVATIONAL
2021-04-08
2027-03-30
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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CF patients with chronic M. abscessus infection
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
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
Luminex; scRNAsec
Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses
Healty Controls
Luminex; scRNAsec
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
Eligibility Criteria
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Inclusion Criteria
* Both sexes
* Age \>18 years
* Obtaining informed consent for patients (based on the procedures established by the protocol).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Ospedale San Raffaele
OTHER
Responsible Party
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Nicola Lore
Principal Investigator
Locations
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Ospedale San Raffaele
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BioMol-MA
Identifier Type: -
Identifier Source: org_study_id
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