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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOspedale San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients unable to understand the instructions and information provided and be able to adequately accept the study methods.

Trial population

Patients with cystic fibrosis

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Luminex; scRNAsec

    Other intervention

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

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: CF patients with chronic M. abscessus infection1 intervention
Group B: CF patients with M. abscessus pulmonary disease1 intervention
Group C: CF patients with no history of M. abscessus infection1 intervention
Group D: Healty Controls1 intervention

Trial outcomes

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

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

Time frame
One month after enrollment visit

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ospedale San Raffaele

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator