HOXB7 and Linked Tissue and Blood Biomarkers in the Lungs of Patients With Pulmonary Fibrosis (HOGWARTS)

February 3, 2026 updated by: Roberto Tonelli, University of Modena and Reggio Emilia
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Modena, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico di Modena
        • Contact:
          • Roberto Tonelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Refusal to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Patients undergoing surgical lung biopsy/criobiopsy for clinical purpose in the diagnostic work-up of ILD.
Procedure: Biopsy

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
Controls
Patients undergoing lung lobectomy for lung cancer suspicion.
Procedure: Biopsy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOXB7 Expression
Time Frame: Baseline
HOXB7 gene and protein expression in lung biopsy samples
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of RNA content
Time Frame: Baseline
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
Baseline
Assessment of proteins content
Time Frame: Baseline
Comparison of protein content between surgical and cryobiopsy samples
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UModenaReggio20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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