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RecruitingNCT07373288HOGWARTSUpdated Feb 4, 2026

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

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

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Fibrosis, Pulmonary

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Keywords

  • Idiopathic pulmonary fiborsis
  • Criobiopsy
  • Lung proteomic
  • Lung transcriptomic
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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

- Refusal to sign informed consent

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureBiopsy

    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

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What researchers measure

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

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Study locations

1 of 1 sites recruiting
  • Azienda Ospedaliero Universitaria Policlinico di Modena
    Modena, Italy
    • Roberto Tonelli · Contact
    Recruiting
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Registry details

Key details

Study ID
NCT07373288
Lead sponsor
University of Modena and Reggio Emilia
Responsible party
Roberto Tonelli (Principal investigator, University of Modena and Reggio Emilia) — Principal investigator
First posted
Jan 28, 2026
Start date
Jul 1, 2023
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2030 (estimated)
Last update
Feb 4, 2026

Study contacts

Roberto Tonelli
Contact
rtonelli@unimore.it
+390594225934

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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