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

NCT07373288 | Recruiting

• 1 other identifier: UModenaReggio20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Idiopathic pulmonary fiborsis; Criobiopsy; Lung proteomic; Lung transcriptomic

Outcome Measures

Primary Outcomes (1)

• HOXB7 Expression

  HOXB7 gene and protein expression in lung biopsy samples

  Baseline

Secondary Outcomes (2)

• Assessment of RNA content

  Baseline

• Assessment of proteins content

  Baseline

Study Arms (2)

Cases

Patients undergoing surgical lung biopsy/criobiopsy for clinical purpose in the diagnostic work-up of ILD.

Procedure: Biopsy

Controls

Patients undergoing lung lobectomy for lung cancer suspicion.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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

Cases; Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Refusal to sign informed consent

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Roberto Tonelli

CONTACT

+390594225934; rtonelli@unimore.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: January 28, 2026
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

IT (1)