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Saliva test may reveal hidden spread of oral cancer

NCT ID NCT07692360

Knowledge-focused Sponsor: University of Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study investigates whether substances in saliva, specifically interleukin-6 levels and certain gene variations, can indicate whether oral cancer has spread to lymph nodes in the neck. Researchers will collect saliva samples from adults with oral squamous cell carcinoma before they begin treatment. The goal is to find biological markers that could help doctors better understand and predict the behavior of the cancer, potentially leading to more personalized treatment plans.

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 saliva test that helps doctors determine how aggressive an oral cancer is and guide treatment decisions.
What could go wrong
This is a small, early observational study. The markers may not prove reliable enough for clinical use, and results may not apply to all patients.

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 38 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

The study population will include adult patients with histopathologically confirmed oral squamous cell carcinoma of the oral cavity, enrolled before any OSCC-specific oncological treatment. Participants will be classified according to regional lymph node status into two observational cohorts: OSCC N0M0, defined as absence of regional lymph node metastasis and absence of distant metastasis, and OSCC N+M0, defined as presence of regional lymph node metastasis and absence of distant metastasis. Patients will be recruited from participating Italian study centres involved in the clinical management of oral squamous cell carcinoma.

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: * Age 18 years or older * Histopathologically confirmed diagnosis of oral squamous cell carcinoma of the oral cavity * Oral squamous cell carcinoma site excluding oropharyngeal sites * Defined regional lymph node status allowing classification as OSCC N0M0 or OSCC N+M0 * Absence of distant metastasis, classified as M0 * Saliva sample collection feasible before any OSCC-specific oncological treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy * Suitability for saliva collection using a standardized absorbent swab * Availability of biological material for genotyping * Ability to provide written informed consent for study participation, biological sampling, and genetic analysis Exclusion Criteria: * Age younger than 18 years * Oral squamous cell carcinoma involving oropharyngeal sites * Presence of distant metastasis * Previous OSCC-specific oncological treatment before saliva sample collection * Acute infection at the time of sampling or within the previous 2 weeks * Active or inadequately controlled systemic autoimmune or inflammatory disease that may significantly alter cytokine profiles * Systemic immunosuppressive or immunomodulatory therapy within the previous 4 to 8 weeks * Recent oncological treatment for malignancies other than OSCC within the previous 6 months, if considered potentially interfering with the immune-inflammatory profile * Clinically significant acute oral infection or inflammatory process at the time of sampling * Active oral bleeding or evident blood contamination of the salivary swab Invasive dental procedures within the previous 2 weeks * Systemic antibiotic therapy within the previous 2 weeks * Inability to provide written informed consent

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Conditions

The condition(s) this trial relates to.

oral cavity 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.

Oral squamous cell carcinoma (OSCC)

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

  • Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

    Pavia, Lombardy, 27100, Italy

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