About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Biopsy
Procedure/SurgeryThis 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
Treatment groups
Trial outcomes
Primary outcomes
HOXB7 Expression
HOXB7 gene and protein expression in lung biopsy samples
Secondary outcomes
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
Assessment of proteins content
Comparison of protein content between surgical and cryobiopsy samples
Sponsors and contacts
Click on the lead sponsor to view all of their trials.