Simple test for throat cancer on the horizon?
NCT ID NCT06356272
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
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About 560 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2019
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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- Can new tracers make many cancers light up on scans?
- Can MRI-Guided radiation boost the power of immunotherapy in head and neck cancer?
- Can tumor genetics unlock gentler treatments for head and neck cancer?