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Blood test may reveal hidden tumor secrets in head and neck cancer

NCT ID NCT07512921

Knowledge-focused Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a simple blood test can give the same information about a tumor's biology as testing the tumor tissue itself. Researchers will collect blood samples from 300 adults with HPV-negative head and neck cancer before and after standard treatment. They will compare gene activity and other markers in the blood to those in stored tumor samples. No new drugs are tested—the goal is to see if a blood test could one day help monitor cancer after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test that monitors tumor biology after treatment, helping doctors personalize care without repeated tissue biopsies.
What could go wrong
This is an early observational study, not a treatment trial. The blood test may not match tumor findings accurately, and results may not change current care for years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Loco-regionally advanced HPV-unrelated HNSCC adult patients amenable to treatments with curative intent.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathologic diagnosis of HNSCC * Primary HNSCC arising from the following sites of head and neck: oral cavity, p16-negative oropharynx, hypopharynx, larynx * Stage III-IVa/b according to the eighth edition of AJCC/UICC classification * Treatment with curative intent * Unequivocal clinical and/or radiological absence of metastatic disease * Patient ability and availability to comply with study protocol procedures.- Exclusion Criteria: * Recurrent/metastatic HNSCC * p16+ oropharyngeal squamous cell carcinoma * Evidence of high-risk HPV infection at tumor level * Cancer of unknown primary site * Non-squamous head and neck cancers (e.g., lymphoma, sarcoma, melanoma, salivary gland cancers) * Skin squamous cell carcinoma from the skin of the head and neck * Nasopharyngeal carcinoma * Sinonasal/paranasal cancers * Insufficient data about previous medical history.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck (HNSCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria di Sassari

    RECRUITING

    Sassari, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

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