COPDRESPIRONCT07707245
Identification of Diagnostic and Prognostic Biomarkers in the Pathological Continuum of Bronco Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Pulmonary Neoplasia
A study testing Peripheral Blood Collection in people with COPD and Idiopathic Pulmonary Fibrosis (IPF), run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Primary Objective: To evaluate the association between inflammatory, immunological, genetic, and epigenetic biomarkers measured at enrollment and the clinical, functional, and phenotypic characteristics of patients with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Idiopathic Pulmonary Fibrosis (IPF), Lung Cancer
- What is being tested?
- Peripheral Blood Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2026to 30 Oct 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Clinical diagnosis of: Chronic Obstructive Pulmonary Disease (COPD), current or former smokers; and/or Idiopathic Pulmonary Fibrosis (IPF), current or former smokers; and/or Resectable lung adenocarcinoma (Stage I-III, according to clinical indication for surgical resection).
- Ability to comply with study procedures and follow-up visits.
Who cannot join
- Inability or unwillingness to provide informed consent.
- Active respiratory infection or acute exacerbation of COPD or IPF at the time of enrollment.
- Previous or concomitant malignant disease (except non-melanoma skin cancer) that could interfere with study objectives.
- Prior systemic immunosuppressive or anti-inflammatory therapy that may significantly alter immune profiling within a defined washout period (if applicable per protocol).
- Severe comorbid conditions limiting life expectancy or ability to complete follow-up (e.g., advanced heart failure, severe renal or hepatic disease).
- Inadequate biological sample quality or impossibility to obtain required blood samples.
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
IRCCS Fondazione Don Carlo Gnocchi
Milan, Milan, 20148
Simone Agostini, PhD, +390240308375, sagostini@dongnocchi.it
Federica Piancone, PhD, +390240308211, fpiancone@dongnocchi.it
About this study
Primary Objective:
To evaluate the association between inflammatory, immunological, genetic, and epigenetic biomarkers measured at enrollment and the clinical, functional, and phenotypic characteristics of patients with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and lung cancer.
Read more
Secondary Objective:
To assess the prognostic value of the identified biomarkers by evaluating their ability to predict clinical outcomes at 12 months.
Primary Outcome Measure:
Association between baseline inflammatory, immunological, genetic, and epigenetic biomarkers and disease-specific clinical, functional, and phenotypic characteristics assessed at enrollment, including:
COPD: current or former smokers, stratified according to the predominant phenotype (emphysema or bronchiolitis); IPF: rapid progressors, slow progressors, and patients with combined pulmonary fibrosis and emphysema (CPFE); Lung cancer: current smokers, former smokers who quit less than 15 years before enrollment, former smokers who quit 15 years or more before enrollment, and never-smokers.
Secondary Outcome Measure:
Predictive performance of baseline inflammatory, immunological, genetic, and epigenetic biomarkers for 12-month clinical outcomes.
Read the detailed description
This is a non-profit, interventional pilot study without an investigational medicinal product. The study consists of two phases: a prospective phase (Phase I) and a retrospective phase (Phase II).
Study Timeline
The overall study duration will be 30 months, as follows:
Patient enrollment and biological sample collection: 18 months. Follow-up visit: 12 months after enrollment for each participant. Laboratory analyses: 20 months. Statistical analyses: at Month 24 (primary endpoint) and at Month 30 (12-month follow-up analyses).
Phase I - Prospective
Participants enrolled in the prospective phase will undergo study assessments according to the following schedule:
T0 (Baseline): Enrollment. T1: 12-month follow-up after enrollment. Clinical and laboratory data will be collected at baseline (T0) and at the 12-month follow-up visit (T1), as specified in the study schedule of assessments.
Phase II - Retrospective Archived tissue samples will be used.
Study Setting Phase I
The prospective phase will enroll:
40 patients with chronic obstructive pulmonary disease (COPD), current or former smokers; 40 patients with idiopathic pulmonary fibrosis (IPF), current or former smokers; 30 never-smoking patients with resectable Stage I or II lung adenocarcinoma undergoing surgical resection; 30 current or former smoking patients with resectable Stage I, II, or III lung adenocarcinoma undergoing surgical resection.
Patients with COPD and IPF will be recruited during outpatient visits. Patients with lung cancer will be recruited either during the preoperative outpatient evaluation or upon hospital admission for surgical treatment.
Phase II Archived tissue biopsy specimens collected during routine clinical practice, either fresh-frozen or formalin-fixed paraffin-embedded (FFPE).
The retrospective cohort will include samples from:
40 patients with COPD; 40 patients with IPF; 30 never-smoking patients with Stage I or II lung adenocarcinoma; 30 smoking patients with Stage I or II lung adenocarcinoma. Study Procedures Phase I - Prospective
Following written informed consent, all participants will undergo collection of approximately 40 mL of peripheral blood:
Three EDTA tubes of whole blood; Two serum tubes.
Peripheral blood mononuclear cells (PBMCs) will be isolated by Ficoll-Paque Plus density-gradient centrifugation, washed with phosphate-buffered saline (PBS), counted, and processed as follows:
Immunophenotypic characterization of innate and adaptive immune cell markers using monoclonal antibody staining and flow cytometry; In vitro stimulation with culture medium alone and with lipopolysaccharide (LPS) plus nigericin to evaluate NLRP3 inflammasome activation; Cryopreservation of a PBMC aliquot in dimethyl sulfoxide (DMSO) at -140°C until analysis.
Serum samples will undergo:
Automated extraction of microRNAs using commercially available column-based extraction kits; Reverse transcription into complementary DNA (cDNA), with storage at -20°C until analysis.
PBMCs will also be used for:
Genomic DNA extraction using the phenol-chloroform method, followed by storage at -20°C until analysis.
Phase II - Retrospective
Archived fresh-frozen and FFPE tissue samples collected during routine clinical care will be retrieved from the participating biobank and pathology department.
Patients whose biological samples are eligible for inclusion will be contacted to obtain specific informed consent for the use of their archived specimens for the present research project. Only samples from participants providing written informed consent will be included.
From FFPE tissue samples:
Genomic DNA will be extracted using the QIAamp DNA FFPE Tissue Kit (Qiagen) and an automated extraction platform, then stored at -20°C until analysis.
MicroRNAs will be extracted using the RNeasy FFPE Kit (Qiagen) and an automated extraction platform, reverse-transcribed into cDNA, and stored at -20°C until analysis.
In addition to the translational research analyses specified in the protocol, results from routine molecular diagnostic testing previously performed on retrospective lung tumor specimens will also be collected. These include PD-L1 expression analysis in squamous cell carcinomas and Myriapod next-generation sequencing (NGS) mutational profiling (DNA and RNA) in lung adenocarcinomas. These molecular variables will be included as covariates in the statistical analyses.
- Conditions
- COPD, Idiopathic Pulmonary Fibrosis (IPF), Lung Cancer
- Being tested
- Peripheral Blood Collection
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Blood CollectionProcedure or surgery
Peripheral venous blood collection (approximately 40 mL) for inflammatory, immunological, genetic, and epigenetic biomarker analyses, including PBMC isolation, serum collection, genomic DNA extraction, and microRNA analysis.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker Assessment | Experimental | Participants with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), or resectable lung carcinoma will undergo peripheral blood collection at baseline for inflammatory, immunological, genetic, and epigenetic biomarker analyses. Clinical and functional data will be collected at baseline, and participants will undergo a 12-month follow-up to evaluate the prognostic value of the identified biomarkers. Receives: Procedure: Peripheral Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Innate immunity
Macrophages, monocytes, neutrophils, and dendritic cells (for all: % of total blood cells)
Measured: Baseline
Genetic polymorphisms
KIR, HLA-Cw, VDR, GC1, IL-1β, IL-1Ra, IL-6, IL-10, IL-13, IL-18, TGF-β1, TNF-α (for all: presence or absence)
Measured: baseline
Adaptive immunity
CTLA-4, PD-1, PDL-1, PDL-2, Galectin-9, LAG-3, TIM-3, VISTA, TIGIT, IL-10, TGF-β, IL-13, IL-35, IL-17 IL-21, IL-1β, IL-6, IL-23, IL-22 (for all: ng/ml)
Measured: baseline
serum microRNAs
serum miR-155-5p, miR-146a-5p, miR-181a-5p, miR-223-3p, miR-431-5p, miR-149-3p, miR-335-5p and miR-206 (for all: copies/ul)
Measured: baseline
Forced Expiratory Volume in 1 second
Forced Expiratory Volume in 1 second (FEV1) (%)
Measured: baseline and after 12 months
VC
Vital Capacity (VC) (%)
Measured: baseline and after 12 months
Total Lung Capacity
Total Lung Capacity (TLC) (%)
Measured: baseline and after 12 months
Inspiratory Capacity
Inspiratory Capacity (IC) (%)
Measured: baseline and after 12 months
Expiratory Reserve Volume
Expiratory Reserve Volume (ERV) %)
Measured: Baseline and after 12 months
Residual Volume
Residual Volume (RV) (%)
Measured: Baseline and after 12 months
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
Measured: Baseline and after 12 months
Blood gas analysis - PaO2
PaO2 (mmHg)
Measured: Baseline and after 12 months
Blood gas analysis - PaCO2
PaCO2 (mmHg)
Measured: baseline and after 12 months
Test 6 minute walk
Test 6 minute walk (metres)
Measured: baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start22 Apr 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Trust Franco e Piero Gazzarrini
- Responsible party
- Sponsor
- Investigators
- Mario Clerici, MD, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707245
- Sponsor's protocol ID
- RESPIRO
- Acronym
- RESPIRO
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy and confidentiality concerns related to the detailed clinical and multi-omics nature of the dataset and the potential risk of re-identification in rare or stratified patient subgroups.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Diagnostic and Prognostic Biomarkers in the Pathological Continuum of Bronco Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Pulmonary Neoplasia
- ClinicalTrials.gov ID
- NCT07707245
- Acronym / sponsor ID
- RESPIRO / RESPIRO
- Conditions
- COPD, Idiopathic Pulmonary Fibrosis (IPF), Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Trust Franco e Piero Gazzarrini
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 16 Jul 2026 (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.
Primary Objective:
To evaluate the association between inflammatory, immunological, genetic, and epigenetic biomarkers measured at enrollment and the clinical, functional, and phenotypic characteristics of patients with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and lung cancer.
Secondary Objective:
To assess the prognostic value of the identified biomarkers by evaluating their ability to predict clinical outcomes at 12 months.
Primary Outcome Measure:
Association between baseline inflammatory, immunological, genetic, and epigenetic biomarkers and disease-specific clinical, functional, and phenotypic characteristics assessed at enrollment, including:
COPD: current or former smokers, stratified according to the predominant phenotype (emphysema or bronchiolitis); IPF: rapid progressors, slow progressors, and patients with combined pulmonary fibrosis and emphysema (CPFE); Lung cancer: current smokers, former smokers who quit less than 15 years before enrollment, former smokers who quit 15 years or more before enrollment, and never-smokers.
Secondary Outcome Measure:
Predictive performance of baseline inflammatory, immunological, genetic, and epigenetic biomarkers for 12-month clinical outcomes.
Detailed description
This is a non-profit, interventional pilot study without an investigational medicinal product. The study consists of two phases: a prospective phase (Phase I) and a retrospective phase (Phase II).
Study Timeline
The overall study duration will be 30 months, as follows:
Patient enrollment and biological sample collection: 18 months. Follow-up visit: 12 months after enrollment for each participant. Laboratory analyses: 20 months. Statistical analyses: at Month 24 (primary endpoint) and at Month 30 (12-month follow-up analyses).
Phase I - Prospective
Participants enrolled in the prospective phase will undergo study assessments according to the following schedule:
T0 (Baseline): Enrollment. T1: 12-month follow-up after enrollment. Clinical and laboratory data will be collected at baseline (T0) and at the 12-month follow-up visit (T1), as specified in the study schedule of assessments.
Phase II - Retrospective Archived tissue samples will be used.
Study Setting Phase I
The prospective phase will enroll:
40 patients with chronic obstructive pulmonary disease (COPD), current or former smokers; 40 patients with idiopathic pulmonary fibrosis (IPF), current or former smokers; 30 never-smoking patients with resectable Stage I or II lung adenocarcinoma undergoing surgical resection; 30 current or former smoking patients with resectable Stage I, II, or III lung adenocarcinoma undergoing surgical resection.
Patients with COPD and IPF will be recruited during outpatient visits. Patients with lung cancer will be recruited either during the preoperative outpatient evaluation or upon hospital admission for surgical treatment.
Phase II Archived tissue biopsy specimens collected during routine clinical practice, either fresh-frozen or formalin-fixed paraffin-embedded (FFPE).
The retrospective cohort will include samples from:
40 patients with COPD; 40 patients with IPF; 30 never-smoking patients with Stage I or II lung adenocarcinoma; 30 smoking patients with Stage I or II lung adenocarcinoma. Study Procedures Phase I - Prospective
Following written informed consent, all participants will undergo collection of approximately 40 mL of peripheral blood:
Three EDTA tubes of whole blood; Two serum tubes.
Peripheral blood mononuclear cells (PBMCs) will be isolated by Ficoll-Paque Plus density-gradient centrifugation, washed with phosphate-buffered saline (PBS), counted, and processed as follows:
Immunophenotypic characterization of innate and adaptive immune cell markers using monoclonal antibody staining and flow cytometry; In vitro stimulation with culture medium alone and with lipopolysaccharide (LPS) plus nigericin to evaluate NLRP3 inflammasome activation; Cryopreservation of a PBMC aliquot in dimethyl sulfoxide (DMSO) at -140°C until analysis.
Serum samples will undergo:
Automated extraction of microRNAs using commercially available column-based extraction kits; Reverse transcription into complementary DNA (cDNA), with storage at -20°C until analysis.
PBMCs will also be used for:
Genomic DNA extraction using the phenol-chloroform method, followed by storage at -20°C until analysis.
Phase II - Retrospective
Archived fresh-frozen and FFPE tissue samples collected during routine clinical care will be retrieved from the participating biobank and pathology department.
Patients whose biological samples are eligible for inclusion will be contacted to obtain specific informed consent for the use of their archived specimens for the present research project. Only samples from participants providing written informed consent will be included.
From FFPE tissue samples:
Genomic DNA will be extracted using the QIAamp DNA FFPE Tissue Kit (Qiagen) and an automated extraction platform, then stored at -20°C until analysis.
MicroRNAs will be extracted using the RNeasy FFPE Kit (Qiagen) and an automated extraction platform, reverse-transcribed into cDNA, and stored at -20°C until analysis.
In addition to the translational research analyses specified in the protocol, results from routine molecular diagnostic testing previously performed on retrospective lung tumor specimens will also be collected. These include PD-L1 expression analysis in squamous cell carcinomas and Myriapod next-generation sequencing (NGS) mutational profiling (DNA and RNA) in lung adenocarcinomas. These molecular variables will be included as covariates in the statistical analyses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker Assessment | Experimental | Procedure: Peripheral Blood CollectionParticipants with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), or resectable lung carcinoma will undergo peripheral blood collection at baseline for inflammatory, immunological, genetic, and epigenetic biomarker analyses. Clinical and functional data will be collected at baseline, and participants will undergo a 12-month follow-up to evaluate the prognostic value of the identified biomarkers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Clinical diagnosis of: Chronic Obstructive Pulmonary Disease (COPD), current or former smokers; and/or Idiopathic Pulmonary Fibrosis (IPF), current or former smokers; and/or Resectable lung adenocarcinoma (Stage I-III, according to clinical indication for surgical resection).
- Ability to comply with study procedures and follow-up visits.
Key exclusion criteria (6 listed)
- Inability or unwillingness to provide informed consent.
- Active respiratory infection or acute exacerbation of COPD or IPF at the time of enrollment.
- Previous or concomitant malignant disease (except non-melanoma skin cancer) that could interfere with study objectives.
- Prior systemic immunosuppressive or anti-inflammatory therapy that may significantly alter immune profiling within a defined washout period (if applicable per protocol).
- Severe comorbid conditions limiting life expectancy or ability to complete follow-up (e.g., advanced heart failure, severe renal or hepatic disease).
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 |
|---|---|---|
| Peripheral Blood CollectionPeripheral venous blood collection (approximately 40 mL) for inflammatory, immunological, genetic, and epigenetic biomarker analyses, including PBMC isolation, serum collection, genomic DNA extraction, and microRNA analysis. | Procedure or surgery | Biomarker Assessment |
Primary outcome
Innate immunity
Time frame: Baseline
Macrophages, monocytes, neutrophils, and dendritic cells (for all: % of total blood cells)
Genetic polymorphisms
Time frame: baseline
KIR, HLA-Cw, VDR, GC1, IL-1β, IL-1Ra, IL-6, IL-10, IL-13, IL-18, TGF-β1, TNF-α (for all: presence or absence)
Adaptive immunity
Time frame: baseline
CTLA-4, PD-1, PDL-1, PDL-2, Galectin-9, LAG-3, TIM-3, VISTA, TIGIT, IL-10, TGF-β, IL-13, IL-35, IL-17 IL-21, IL-1β, IL-6, IL-23, IL-22 (for all: ng/ml)
serum microRNAs
Time frame: baseline
serum miR-155-5p, miR-146a-5p, miR-181a-5p, miR-223-3p, miR-431-5p, miR-149-3p, miR-335-5p and miR-206 (for all: copies/ul)
Forced Expiratory Volume in 1 second
Time frame: baseline and after 12 months
Forced Expiratory Volume in 1 second (FEV1) (%)
VC
Time frame: baseline and after 12 months
Vital Capacity (VC) (%)
Total Lung Capacity
Time frame: baseline and after 12 months
Total Lung Capacity (TLC) (%)
Inspiratory Capacity
Time frame: baseline and after 12 months
Inspiratory Capacity (IC) (%)
Expiratory Reserve Volume
Time frame: Baseline and after 12 months
Expiratory Reserve Volume (ERV) %)
Residual Volume
Time frame: Baseline and after 12 months
Residual Volume (RV) (%)
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
Time frame: Baseline and after 12 months
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
Blood gas analysis - PaO2
Time frame: Baseline and after 12 months
PaO2 (mmHg)
Blood gas analysis - PaCO2
Time frame: baseline and after 12 months
PaCO2 (mmHg)
Test 6 minute walk
Time frame: baseline and after 12 months
Test 6 minute walk (metres)
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 Jul 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy and confidentiality concerns related to the detailed clinical and multi-omics nature of the dataset and the potential risk of re-identification in rare or stratified patient subgroups.
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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.
Mario Clerici, MD principal investigator
IRCCS Fondazione Don Carlo Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Blood Collection in people with COPD and Idiopathic Pulmonary Fibrosis (IPF), run by Fondazione Don Carlo Gnocchi ETS 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 3 inclusion and 6 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 Jul 2026. 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 Mario Clerici, MD (+39024030801, mario.clerici@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Innate immunity (time frame: Baseline). The study lists 14 primary outcomes in all. 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 Jul 2026.