Identifying new biological markers for lung disease in cystic fibrosis patients
Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
Ospedale San Raffaele · NCT06413459
This study is trying to find new biological markers in cystic fibrosis patients to better understand and track lung disease caused by Mycobacterium abscessus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ospedale San Raffaele (other) |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06413459 on ClinicalTrials.gov |
What this trial studies
This project aims to identify new biological markers by characterizing the immune response and inflammation associated with Mycobacterium abscessus lung disease in cystic fibrosis patients. The main objective is to evaluate the correlation between early changes in specific cell populations and soluble immunity activation proteins with the progression of lung disease. Secondary objectives include identifying cellular expression profiles and biomarkers that can predict clinical outcomes, as well as expanding knowledge on the disease's progression. The study utilizes advanced techniques such as Luminex and single-cell RNA sequencing.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of cystic fibrosis.
Not a fit: Patients who are unable to understand the study instructions or consent process may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of lung disease in cystic fibrosis patients infected with M. abscessus.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for lung diseases, but this specific approach is relatively novel.
Eligibility criteria
Show full 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.
Where this trial is running
Milan, MI
- Ospedale San Raffaele — Milan, MI, Italy (RECRUITING)
Study contacts
- Study coordinator: Nicola I Lorè, PhD
- Email: lore.nicolaivan@hsr.it
- Phone: +390226434902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis Lung, scRNASec