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NCT Number: NCT07373288

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

Location status: Recruiting

Location contact

Roberto Tonelli

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Refusal to sign informed consent

Treatment and study plan

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

Primary outcomes

  1. HOXB7 Expression

    Time frame: Baseline

    HOXB7 gene and protein expression in lung biopsy samples

Secondary outcomes

  1. Assessment of RNA content

    Time frame: Baseline

    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

  2. Assessment of proteins content

    Time frame: Baseline

    Comparison of protein content between surgical and cryobiopsy samples

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Tonelli

CONTACT

[email protected]

+390594225934

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Acronym: HOGWARTS

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Jan 28, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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