NCT07508319

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 19, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 23, 2026

Last Update Submit

March 31, 2026

Conditions

Head & Neck Cancer

Keywords

Laryngeal dysplasia

Outcome Measures

Primary Outcomes (1)

  • differences in TILs counts

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

    2 years

Secondary Outcomes (1)

  • Differences in TILs counts in LDy lesions

    2 years

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Histopathological diagnosis of laryngeal dysplasia.
  • Age \>18 years and informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, MI, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Marta Tagliabue, MD

    Istituto Europeo di Oncologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Tagliabue, MD

CONTACT

00390257489405marta.tagliabue@ieo.it

francesca lombardi

CONTACT

00390257489425francesca.lombardi@ieo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 2, 2026

Study Start

November 19, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

IT(1)