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Recruiting

NCT Number: NCT07508319

Role of the Immune System in Preventing Laryngeal Cancer

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

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology

Milan, MI, 20141, Italy

Location status: Recruiting

Location contact

Marta Tagliabue, MD

CONTACT

[email protected]

00390257489495

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. differences in TILs counts

    Time frame: 2 years

    detection of differences in TILs counts from Laryngeal dysplasia to progression to carcinoma

Secondary outcomes

  1. 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

Study contacts

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

Marta Tagliabue, MD

CONTACT

[email protected]

00390257489405

francesca lombardi

CONTACT

[email protected]

00390257489425

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 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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