Blood test could predict cancer return after surgery
NCT ID NCT04099290
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at a blood test that measures tiny bits of tumor DNA floating in the blood. Researchers will enroll 50 adults with head and neck cancer who are planning surgery. They want to see how these DNA levels change after surgery and whether they can help predict if the cancer will come back.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Feb 2027
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
Patients with Head and Neck Cancer
- 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: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and/or surgical resection (archival tissue) and serial blood draws will be required for enrollment. * Age ≥ 18 years of age on day of signing informed consent * Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx * Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital * No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1/T2 must have nodal involvement), Any N, M0 * Patient must be amenable to receiving adjuvant therapy with radiotherapy +/- systemic therapy, as clinically indicated, based on either standard of care (SOC) or appropriate clinical trial. * Diagnostic tumor material must be available for correlative analysis * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee Exclusion Criteria: * Has known evidence of metastatic disease based on clinical or radiographic studies * Women who are pregnant or nursing * History of another primary malignancy in the last 5 years prior to registration. Patients with history of in situ cancer or basal or localized squamous cell skin cancers are eligible. * Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers * Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
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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
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
Locations
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University of North Carolina at Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27599, United States
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- Can a new targeted drug outperform standard therapy for advanced head and neck cancer?
- Can MRI-Guided radiation boost the power of immunotherapy in head and neck cancer?