Role of the Immune System in Preventing Laryngeal Cancer | NCT07508319

Studies
Role of the Immune System in Preventing Laryngeal Cancer

NCT07508319

Sponsor

European Institute of Oncology

Status

Recruiting

Last Update Posted

Apr 2, 2026Actual

Enrollment

3Estimated

Phase

Not provided

Conditions

Head & Neck Cancer

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
L2-401	Other Identifier	Comitato Etico Territoriale Lombardia 2

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 23, 2026

First Submission Date that Met QC Criteria

Mar 31, 2026

First Posted Date

Apr 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marta Tagliabue, MD	Contact	00390257489405		marta.tagliabue@ieo.it
francesca lombardi	Contact	00390257489425		francesca.lombardi@ieo.it

Overall Officials

Name	Affiliation	Role
Marta Tagliabue, MD	Istituto Europeo di Oncologia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
European Institute of Oncology	Recruiting	Milan	MI	20141	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided