Head & Neck CancerNCT07508319
Role of the Immune System in Preventing Laryngeal Cancer
An observational study of Head & Neck Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Laryngeal dysplasia and progression to carcinoma: investigating genetic and immune alterations predictive of malignant transformation Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head & Neck Cancer
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will recruit 150 consecutive, untreated LDy patients, potentially within a multicenter framework.
Who may be able to join
- Histopathological diagnosis of laryngeal dysplasia.
- Age >18 years and informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, MI, 20141
Marta Tagliabue, MD, 00390257489495, marta.tagliabue@ieo.it
About this study
Official title: 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
Read the 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.
- Conditions
- Head & Neck Cancer
- Keywords
- Laryngeal dysplasia
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in TILs counts
detection of differences in TILs counts from Laryngeal dysplasia to progression to carcinoma
Measured: 2 years
Secondary outcomes (1)
Differences in TILs counts in LDy lesions
Detection of Differences in TILs counts in LDy lesions categorized by their risk of malignant progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start19 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Tagliabue, MD, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508319
- Sponsor's protocol ID
- UID 4973
- Other IDs
- L2-401
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Dysplasia and Progression to Carcinoma: Investigating Genetic and Immune Alterations Predictive of Malignant Transformation
- ClinicalTrials.gov ID
- NCT07508319
- Acronym / sponsor ID
- UID 4973
- Conditions
- Head & Neck Cancer
- Keywords
- Laryngeal dysplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 150 consecutive, untreated LDy patients, potentially within a multicenter framework.
Key inclusion criteria (2 listed)
- Histopathological diagnosis of laryngeal dysplasia.
- Age >18 years and informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
differences in TILs counts
Time frame: 2 years
detection of differences in TILs counts from Laryngeal dysplasia to progression to carcinoma
1 secondary outcome
Differences in TILs counts in LDy lesions
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Tagliabue, MD principal investigator
Istituto Europeo di Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head & Neck Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Tagliabue, MD (00390257489405, marta.tagliabue@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in TILs counts (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.