Fibrosis, PulmonaryHOGWARTSNCT07373288
HOXB7 and Linked Tissue and Blood Biomarkers in the Lungs of Patients With Pulmonary Fibrosis
An observational study of Fibrosis, Pulmonary, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
This pilot, multicenter, interventional study investigates the expression of HOXB7 and its associated molecular pathway in lung tissue and blood-derived exosomes from patients with pulmonary fibrosis (PF), including idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibrosis, Pulmonary
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 1 Jul 2030
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients aged 18 to 80 years with clinical suspicion of pulmonary fibrosis, admitted to the Center for Rare Lung Diseases (MaRP) at the University Hospital of Modena (AOU Policlinico di Modena), or to collaborating centers. An additional control group will consist of adult patients undergoing lung resection for reasons unrelated to fibrotic interstitial lung diseases (e.g., neoplastic conditions), enrolled at the same institutions.
Who may be able to join
- Adults aged 18 to 80 with clinical suspicion of pulmonary fibrosis
- Availability of fresh lung tissue from biopsy or lung explant
- Signed informed consent for research use of biological material and data
Who cannot join
- Refusal to sign informed consent
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
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena
Roberto Tonelli
About this study
This pilot, multicenter, interventional study investigates the expression of HOXB7 and its associated molecular pathway in lung tissue and blood-derived exosomes from patients with pulmonary fibrosis (PF), including idiopathic pulmonary fibrosis (IPF). Using RNA sequencing (RNA-Seq) and proteomic analysis via mass spectrometry (MS), the study aims to identify tissue and circulating biomarkers associated with fibrosis progression. The study compares different biopsy techniques (surgical vs. transbronchial cryobiopsy) and also includes a control group of patients undergoing lung resection for non-fibrotic conditions.
- Conditions
- Fibrosis, Pulmonary
- Being tested
- Biopsy
- Keywords
- Idiopathic pulmonary fiborsis, Criobiopsy, Lung proteomic, Lung transcriptomic
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
This is a non-therapeutic, observational sampling study. Procedures include:
Lung tissue sampling via:
Surgical biopsy Transbronchial cryobiopsy Explanted lungs from transplant patients Blood sampling for exosome analysis
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients undergoing surgical lung biopsy/criobiopsy for clinical purpose in the diagnostic work-up of ILD. Receives: Procedure: Biopsy | |
| Controls | Patients undergoing lung lobectomy for lung cancer suspicion. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOXB7 Expression
HOXB7 gene and protein expression in lung biopsy samples
Measured: Baseline
Secondary outcomes (2)
Assessment of RNA content
Comparison of RNA content between surgical and cryobiopsy samples Identification of HOXB7-positive LR-MSCs from fresh biopsy tissue Exosomal biomarkers associated with HOXB7 expression in serum Feasibility and yield of RNA-Seq and proteomics from fresh vs. snap-frozen tissues
Measured: Baseline
Assessment of proteins content
Comparison of protein content between surgical and cryobiopsy samples
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jul 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosis, PulmonaryStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Tonelli, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373288
- Sponsor's protocol ID
- UModenaReggio20
- Acronym
- HOGWARTS
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOXB7 and Linked Tissue and Blood Biomarkers in the Lungs of Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07373288
- Acronym / sponsor ID
- HOGWARTS / UModenaReggio20
- Conditions
- Fibrosis, Pulmonary
- Keywords
- Idiopathic pulmonary fiborsis, Criobiopsy, Lung proteomic, Lung transcriptomic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 28 Jan 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.
This pilot, multicenter, interventional study investigates the expression of HOXB7 and its associated molecular pathway in lung tissue and blood-derived exosomes from patients with pulmonary fibrosis (PF), including idiopathic pulmonary fibrosis (IPF). Using RNA sequencing (RNA-Seq) and proteomic analysis via mass spectrometry (MS), the study aims to identify tissue and circulating biomarkers associated with fibrosis progression. The study compares different biopsy techniques (surgical vs. transbronchial cryobiopsy) and also includes a control group of patients undergoing lung resection for non-fibrotic conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: BiopsyPatients undergoing surgical lung biopsy/criobiopsy for clinical purpose in the diagnostic work-up of ILD. |
| Controls | – | Procedure: BiopsyPatients undergoing lung lobectomy for lung cancer suspicion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients aged 18 to 80 years with clinical suspicion of pulmonary fibrosis, admitted to the Center for Rare Lung Diseases (MaRP) at the University Hospital of Modena (AOU Policlinico di Modena), or to collaborating centers. An additional control group will consist of adult patients undergoing lung resection for reasons unrelated to fibrotic interstitial lung diseases (e.g., neoplastic conditions), enrolled at the same institutions.
Key inclusion criteria (3 listed)
- Adults aged 18 to 80 with clinical suspicion of pulmonary fibrosis
- Availability of fresh lung tissue from biopsy or lung explant
- Signed informed consent for research use of biological material and data
Key exclusion criteria (1 listed)
- Refusal to sign informed consent
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 |
|---|---|---|
| BiopsyThis is a non-therapeutic, observational sampling study. Procedures include: Lung tissue sampling via: Surgical biopsy Transbronchial cryobiopsy Explanted lungs from transplant patients Blood sampling for exosome analysis | Procedure or surgery | Cases, Controls |
Primary outcome
HOXB7 Expression
Time frame: Baseline
HOXB7 gene and protein expression in lung biopsy samples
2 secondary outcomes
Assessment of RNA content
Time frame: Baseline
Assessment of proteins content
Time frame: Baseline
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 4 Feb 2026.
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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 Fibrosis, Pulmonary, run by University of Modena and Reggio Emilia 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 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 4 Feb 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 Roberto Tonelli (+390594225934, rtonelli@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOXB7 Expression (time frame: Baseline). 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 4 Feb 2026.