Role of the Immune System in Preventing Laryngeal Cancer

March 31, 2026 updated by: European Institute of Oncology

Laryngeal Dysplasia and Progression to Carcinoma: Investigating Genetic and Immune Alterations Predictive of Malignant Transformation

Laryngeal dysplasia and progression to carcinoma: investigating genetic and immune alterations predictive of malignant transformation

Study Overview

Status

Recruiting

Conditions

Detailed Description

Evaluate the immune population of TILs in LDy lesions with a high or low risk of malignant transformation. Analyze gene expression profiles in LDy lesions categorized by their risk of malignant progression.

Study Type

Observational

Enrollment (Estimated)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will recruit 150 consecutive, untreated LDy patients, potentially within a multicenter framework.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences in TILs counts
Time Frame: 2 years
detection of differences in TILs counts from Laryngeal dysplasia to progression to carcinoma
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in TILs counts in LDy lesions
Time Frame: 2 years
Detection of Differences in TILs counts in LDy lesions categorized by their risk of malignant progression
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Marta Tagliabue, MD, Istituto Europeo di Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UID 4973
  • L2-401 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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