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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Modena and Reggio Emilia

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Biopsy

    Procedure/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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cases1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

HOXB7 Expression

HOXB7 gene and protein expression in lung biopsy samples

Time frame
Baseline

Secondary outcomes

1

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
2

Assessment of proteins content

Comparison of protein content between surgical and cryobiopsy samples

Time frame
Baseline

Other outcomes

Sponsors and contacts

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