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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06413459
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ospedale San Raffaele
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis Lung

Additional Details

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.

Arms & Interventions

Arms

: CF patients with chronic M. abscessus infection

: CF patients with M. abscessus pulmonary disease

: CF patients with no history of M. abscessus infection

: Healty Controls

Interventions

Other: - Luminex; scRNAsec

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.