Non-Tuberculous Mycobacterial PneumoniaBioMol-MANCT06413459
Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
An observational study of Non-Tuberculous Mycobacterial Pneumonia and Cystic Fibrosis Lung, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis Lung
- What is being tested?
- Luminex; scRNAsec
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2021to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with cystic fibrosis
Who may be able to join
- 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).
Who cannot join
- Patients unable to understand the instructions and information provided and be able to adequately accept the study methods.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, MI, 20132
Nicola I Lorè, PhD, +390226434902, nicolaivanlore@hsr.it
About this study
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.
Read the detailed description
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.
- Being tested
- Luminex; scRNAsec
- Keywords
- scRNASec
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminex; scRNAsecOther
Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses
| Study group | Role | What they receive |
|---|---|---|
| CF patients with chronic M. abscessus infection | Not described Receives: Other: Luminex; scRNAsec | |
| CF patients with M. abscessus pulmonary disease | Not described Receives: Other: Luminex; scRNAsec | |
| CF patients with no history of M. abscessus infection | Not described Receives: Other: Luminex; scRNAsec | |
| Healty Controls | Not described Receives: Other: Luminex; scRNAsec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month after enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start8 Apr 2021
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous Mycobacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Lore, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413459
- Sponsor's protocol ID
- BioMol-MA
- Acronym
- BioMol-MA
- Status last verified
- Sep 2023
- First submitted
- 9 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06413459
- Acronym / sponsor ID
- BioMol-MA / BioMol-MA
- Keywords
- scRNASec
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CF patients with chronic M. abscessus infection | – | Other: Luminex; scRNAsec |
| CF patients with M. abscessus pulmonary disease | – | Other: Luminex; scRNAsec |
| CF patients with no history of M. abscessus infection | – | Other: Luminex; scRNAsec |
| Healty Controls | – | Other: Luminex; scRNAsec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cystic fibrosis
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients unable to understand the instructions and information provided and be able to adequately accept the study methods.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luminex; scRNAsecEvaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses | Other | CF patients with M. abscessus pulmonary disease, CF patients with chronic M. abscessus infection, CF patients with no history of M. abscessus infection, Healty Controls |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Tuberculous Mycobacterial Pneumonia and Cystic Fibrosis Lung, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola I Lorè, PhD (+390226434902, lore.nicolaivan@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.