An observational study in Fibrosis, Pulmonary, sponsored by University of Modena and Reggio Emilia. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by University of Modena and Reggio Emilia · Observational
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.
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.
Exclusion Criteria:
- Refusal to sign informed consent
Patients undergoing surgical lung biopsy/criobiopsy for clinical purpose in the diagnostic work-up of ILD.
Procedure: Biopsy
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
HOXB7 Expression
HOXB7 gene and protein expression in lung biopsy samples
Time frame: Baseline
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
Time frame: Baseline
Assessment of proteins content
Comparison of protein content between surgical and cryobiopsy samples
Time frame: Baseline
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University of Modena and Reggio Emilia