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Blood test aims to catch hidden head and neck cancer early

NCT ID NCT04599309

Knowledge-focused Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study is testing whether a blood test can find tiny bits of tumor DNA (ctDNA) or HPV DNA in patients with high-risk head and neck cancer after standard treatment. The goal is to see if this test can detect cancer that remains or comes back earlier than usual scans. The study includes 35 patients with stage III or IV head and neck cancer who are starting standard therapy like surgery, radiation, or chemoradiation.

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 blood test that catches cancer recurrence earlier, potentially improving outcomes for head and neck cancer patients.
What could go wrong
This is a small, early feasibility study (35 participants) focused on detection, not treatment. The test may not reliably predict relapse in all 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.

Participants

35 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Jun 2026

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

Patients with a diagnosis of high risk locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment.

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: * Histologically or cytological confirmed LA-HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx. * Stage III HPV Positive or Stage III-IV HPV negative. * Availability of tumor sample * Patients who are candidates for standard definitive treatment defined as: * Surgery followed by radiotherapy +/- chemotherapy OR * Definite radiotherapy OR * Definite chemoradiotherapy. Exclusion Criteria: * Early stage HNSCC (I and II) * Distant metastatic HNSCC

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Conditions

The condition(s) this trial relates to.

cancer head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma neoplasm Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Cancer Head and neck cancer Head and neck squamous cell carcinoma

Contacts and locations

Locations

  • Princess Margaret Cancer Centre

    Toronto, Ontario, L1M2J2, Canada

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