Immune changes that may stop laryngeal dysplasia from becoming cancer
Official title: Laryngeal Dysplasia and Progression to Carcinoma: Investigating Genetic and Immune Alterations Predictive of Malignant Transformation
Run by European Institute of Oncology · NCT07508319 · Data updated 2026-11-12
This project will see if immune cells and gene activity in adults with laryngeal dysplasia can predict which lesions will turn into cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 3 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | November 19, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT07508319 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with a histopathological diagnosis of laryngeal dysplasia who can give informed consent and have not had prior surgical, radiation, or oncologic treatment to the head and neck are ideal candidates.
✕Probably not a fit
Patients with prior head or neck cancer treatments, congenital or acquired immunodeficiency, synchronous malignancies, current immunosuppressive therapy, or those under 18 are unlikely to benefit from this specific research.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational effort at the European Institute of Oncology enrolling adults with histopathologically confirmed laryngeal dysplasia who have not received prior head and neck cancer treatments. Researchers will profile tumor-infiltrating lymphocyte (TIL) populations in lesion tissue and perform gene expression analysis. Lesions will be categorized by their clinical risk of malignant progression and molecular patterns will be compared between high- and low-risk groups. The goal is to identify immune and genetic markers associated with transformation to invasive carcinoma to inform future monitoring and treatment strategies.
Why it matters
Potential benefit: If successful, the findings could help doctors identify high-risk laryngeal lesions earlier and tailor monitoring or treatment to prevent cancer.
How similar studies have gone: Related studies in other head and neck and squamous precancer settings have shown that TIL profiles and gene-expression signatures can predict progression, but use specifically for laryngeal dysplasia is less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathological diagnosis of laryngeal dysplasia. * Age \>18 years and informed consent. Exclusion Criteria: * Prior surgical, radiotherapeutic, or oncologic treatments for head and neck regions. * Congenital or acquired immunodeficiency disorders. * Synchronous malignancies. * Immunosuppressive therapy. * Age \<18 years or absence of research consent.
Where it's running
-
European Institute of Oncology
Milan, Mi, Italy Recruiting
Study contacts
- Principal investigator: Marta Tagliabue, MD — Istituto Europeo di Oncologia
- Study coordinator: Marta Tagliabue, MD
- Email: marta.tagliabue@ieo.it
- Phone: 00390257489405
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.