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NCT Number: NCT06413459

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Luminex; scRNAsec

Other

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

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

    Time frame: One month after enrollment visit

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicola I Lorè, PhD

CONTACT

[email protected]

+390226434902

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Registry information

Acronym: BioMol-MA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 14, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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