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Blood test may let some throat cancer patients skip radiation after surgery

NCT ID NCT07513389

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 5 times

Summary

This study is for people with HPV-related throat cancer who have surgery to remove the tumor. Normally, some patients also get radiation afterward to lower the risk of cancer coming back. This trial tests whether it's safe to skip that radiation if a blood test two weeks after surgery shows no signs of cancer DNA. Participants will be closely monitored with regular check-ups and blood tests to catch any recurrence early. The goal is to see if avoiding radiation can reduce side effects without compromising cancer control.

What this could mean

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

Active substance
active surveillance with ctHPVDNA blood test (NavDx®)
What this could lead to
If successful, this could allow many patients to avoid the side effects of radiation after surgery, while still catching any recurrence early through a simple blood test.
What could go wrong
This is a small, early-phase trial with only 36 participants, so results may not apply to everyone. There is a risk that skipping radiation could lead to cancer returning in some 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.

Phase

Phase 2

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

Participants

About 36 people

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

Started

Aug 2026

Expected to finish

Jul 2034

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: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, ≥ 18 years of age (no upper age limit). * Biopsy proven squamous cell carcinoma. * p16 positive (diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+ staining intensity). * NavDx positive, HPV16 TTMV only. * AJCC 8th edition cT0-2 N1 M0. * Well lateralized tonsil (\>1 cm from midline, tonsil, base of tongue, glossotonsillar sulcus primary tumors. * ≤ 2 lymph nodes, each ≤ 3cm, -OR- 1 lymph node \>3 but \< 6 cm. * ≤10 pack-years of cigarette smoking or no cigarette smoking for ≥ 5 years (regardless of pack years). * Anatomically (e.g. adequate exposure) and physically amenable to TORS per the judgement of the operating surgeon. * Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to surgery; at a minimum CT imaging of the chest. PET/CT is acceptable. * ECOG Performance Status 0-1. * CBC with differential obtained within 8 weeks prior to surgery, with adequate bone marrow function defined as follows: * Platelets ≥ 100,000 cells/mm3 * Hemoglobin ≥ 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable. Transfusion must be completed within 2 to 4 weeks prior to enrollment.) * Adequate renal and hepatic function within 8 weeks prior to surgery, defined as follows: * Serum creatinine \< 2.0 mg/dl. * Total bilirubin ≤ 1.5 x the institutional ULN. * Negative pregnancy test within 2 weeks prior to surgery for women of childbearing potential. * Eligible for platinum chemotherapy. Chemotherapy drugs allowed: cisplatin, carboplatin/paclitaxel, carboplatin/abraxane, per treating physician (cisplatin preferred, 2nd preference carboplatin/paclitaxel or carboplatin/abraxane). * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional year after surgery per MD discretion. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and/or implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge). Exclusion Criteria: * Prior history of surgery to the head and neck that in the opinion of the investigators would modify prognostic significance of pathology results. * Prior history of radiation therapy to the head and neck, with the exception of skin cancer treated with a small (≤ 9cm3) field with 6 - 9 MeV electron beam or 50 - 250 kVp photon beam. * Prior history within 5 years of cancer with the exception of: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin, stage 1-2 * Prostate cancer without distant metastases (stage M0) * Thyroid cancer without distant metastases (stage M0) * Prior history of squamous cell carcinoma of a mucosal site in the head or neck treated with surgery alone. * Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis. * Current smoker or tobacco user. * Severe, active co-morbidity, defined as one or more of the following: * Unstable angina and/or congestive heart failure requiring inpatient hospitalization within the last 6 months. * Transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. * Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. \--- Note, however, coagulation parameters are not required for entry into this protocol. * Evidence of active systemic lupus or scleroderma. * Psoriatic arthritis. * Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population. \-- Note: HIV testing at the time of enrollment is not required. * Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for the immediate post-op period (1-2 weeks). Females will be determined to be not of child-bearing potential with a history of hysterectomy or with postmenopausal status of \>12 months. * Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting one month prior to screening and for one year after surgery per MD discretion. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

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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

    1 site. 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

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

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Other studies related to the condition(s) this trial covers.