Immune changes that may stop laryngeal dysplasia from becoming cancer
Laryngeal Dysplasia and Progression to Carcinoma: Investigating Genetic and Immune Alterations Predictive of Malignant Transformation
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 |
|---|---|
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT07508319 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, MI
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.