Blood test may spare throat cancer patients from radiation side effects
NCT ID NCT06088381
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 61 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2030
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.
- 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 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.
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The places running it
5 sites. 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
Locations
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Baltimore Washington Medical Center
NOT_YET_RECRUITINGGlen Burnie, Maryland, 21061, United States
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Central Maryland Radiation Oncology
NOT_YET_RECRUITINGColumbia, Maryland, 21044, United States
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Maryland Proton Treatment Center
RECRUITINGBaltimore, Maryland, 21201, United States
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University of Maryland Greenebaum Cancer Center
RECRUITINGBaltimore, Maryland, 21201, United States
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Upper Chesapeake Health
NOT_YET_RECRUITINGBel Air, Maryland, 21014, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- New PET tracer aims to light up hidden cancer targets
- Can immunotherapy before surgery stop early oral cancer from returning?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Can a glowing dye show surgeons where head and neck tumors end?
- Re-irradiation plus cetuximab targets head and neck tumors that return