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Simple test for throat cancer on the horizon?

NCT ID NCT06356272

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 from Mayo Clinic aims to find biological markers (biomarkers) in blood, tissue, and saliva that can signal the presence or absence of HPV-related oropharyngeal cancer. Researchers will follow 560 participants, including patients with and without the disease, to see if these markers can help with diagnosis and tracking outcomes. The goal is to develop a non-invasive way to detect cancer and monitor for recurrence.

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 or saliva test to detect HPV-related throat cancer earlier and monitor for recurrence.
What could go wrong
This is an observational study, not a treatment trial. It may not find a reliable biomarker, and any test developed would need further validation.

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 560 people

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

Started

Nov 2019

Expected to finish

Nov 2029

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

Adults \> 18 years of age with newly diagnosed untreated, progressive, or metastatic oropharyngeal squamous cell carcinoma with known HPV status

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 * Able to provide written consent * Groups 1-3: * Must undergo p16 staining on biopsy for enrollment * Patients with \< 70% of tumor cells positive for p16 will be considered p16 negative * Must undergo HPV16 family in situ hybridization (ISH) and/or RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it * Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol * Group 4: * Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm * Primary salivary neoplasm * Primary thyroid neoplasm * Primary head and neck neoplasm * Multi-cancer early detection (MCED) testing concerning for cancer * Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing * Ability to complete questionnaire(s) by themselves or with assistance * Primary language: English, Spanish, Arabic Exclusion Criteria: * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. * Groups 1-3: * Other active malignancy ≤ 5 years prior to registration * EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3) * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer * History of any head and neck malignancy, other than the tumor for which they are being treated * Group 4, Cohort A, B, C: * Other active malignancy ≤ 5 years prior to registration * EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer * History of any head and neck malignancy, other than the present neoplasm * Note these are clarifications of inclusion into Group 4, Cohorts D and E: * Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm * Receipt of cancer specific therapy for other malignancy is allowed in this arm

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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