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Blood test may spare throat cancer patients from radiation side effects

NCT ID NCT06088381

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for people with HPV-related throat cancer who have surgery to remove their tumor. Researchers are testing whether a blood test that looks for leftover tumor DNA can safely identify patients who do not need additional radiation. The goal is to reduce side effects by giving radiation only to those who truly need it. About 61 participants will be followed for two years to see if the approach works.

What this could mean

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

Active substance
Circulating Tumor DNA (ctDNA) blood test
What this could lead to
If successful, this approach could spare many patients from unnecessary radiation and its side effects after surgery for HPV-related throat cancer.
What could go wrong
This is a small, early-phase trial (61 people) without a comparison group, so results may not apply broadly. The blood test might miss some recurrences or lead to undertreatment.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 61 people

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

Started

Mar 2024

Expected to finish

Dec 2030

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.

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 1. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or p16+ squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site. 2. Does the patient have clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT) with imaging within 60 days of enrollment? 3. Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue? 4. Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary tumor board? 5. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration? 6. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration? 7. Is the patient ≥ 18 years of age? 8. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment. 9. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review? Exclusion Criteria 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx? 2. Does the patient have distant metastasis? 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low/intermediate risk prostate cancer) unless disease free for a minimum of 3 years? 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)? 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields? 6. Did the patient have prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies? 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm? 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements? 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?

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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 places running it

    5 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

  • Baltimore Washington Medical Center

    NOT_YET_RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Central Maryland Radiation Oncology

    NOT_YET_RECRUITING

    Columbia, Maryland, 21044, United States

  • Maryland Proton Treatment Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Maryland Greenebaum Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Upper Chesapeake Health

    NOT_YET_RECRUITING

    Bel Air, Maryland, 21014, United States

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