ClinicalTrials.gg
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

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 4 months later.
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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In context

Pulmonary Fibrosis

342 studies on the registry are indexed under Pulmonary Fibrosis; 98 are open to participants now.

This study's planned enrollment of 80 is below the median of 150 across 118 observational studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

University of Modena and Reggio Emilia is the lead sponsor of 65 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 to 80 with clinical suspicion of pulmonary fibrosis
  • Availability of fresh lung tissue from or lung explant
  • Signed for research use of biological material and data

Exclusion criteria

Exclusion Criteria:

- Refusal to sign

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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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
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Jul 2027, 48 months after the start.

Of 60 observational studies under Pulmonary Fibrosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 111. This study's planned 48 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2025
First posted
Jan 28, 2026
StartActual
Jul 1, 2023
Primary completionEst.
Jul 1, 2027
CompletionEst.
Jul 1, 2030
Last update
Feb 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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