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Observational Study on Personalized Blood Tests for Head and Neck Cancer Recurrence

This study is looking at a new way to predict if head and neck squamous cell carcinoma (HNSCC) will come back after treatment. It uses a personalized blood test to look for tiny amounts of cancer DNA (called circulating tumor DNA or ctDNA). The study wants to see if finding this ctDNA after treatment can accurately tell who will have their cancer return within two years. You might be able to join if you have newly diagnosed Stage III-IVB HNSCC that is not linked to HPV, and if there is enough tissue from your tumor for the special blood test. The study hopes that detecting ctDNA will show cancer recurrence at least three months before it's found by other methods. The main goal is to see how many people are cancer-free two years after treatment, based on whether ctDNA was found in their blood.

Study design
This is an observational study with two groups, aiming to enroll 75 participants. It is not a randomized study, meaning participants are not randomly assigned to different treatments.
What's involved
Participants will have blood draws and tissue samples taken. You will be followed for a minimum of 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 2 years after treatment completion.

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NCT06744296

Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck

Recruiting
Not specifiedAges 18+Observational
Massachusetts Eye and Ear Infirmary
~75 participants
Updated 2025-05-18 on ClinicalTrials.gov
What's tested:Blood Draws and Tissue Sample(s)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2 Years - Disease Free Survival (DFS)
Measured over 2 weeks after treatment completion

Conditions

Squamous Cell Carcinoma of Head and Neck

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Daniel Faden, MD · PRINCIPAL_INVESTIGATOR · Massachusetts Eye and Ear

Who to contact

Michael Cheung, MSc, CCRP
[email protected]
617-573-6060
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx.
Available tissue for tumor-informed ctDNA panel creation.
Definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at Massachusetts Eye and Ear Institute (MEEI) or within the Massachusetts General Hospital (MGH) Cancer Center (including but not limited to the Boston, Danvers, and Newton-Wellesley locations).

Exclusion

Patients \<18 years of age
Patients receiving non-standard of care therapy as determined by the clinical investigator
Participants who have undergone prior surgical resection, excisional biopsy, radiation, and/or chemotherapy for the treatment of HNSCC. Prior incisional biopsies are permitted. Discrepant cases will be reviewed by study PI.
Participants who are receiving any investigational agents at the time of enrollment.
Participants with AJCC Stage IVC HNSCC, which includes patients with biopsy-confirmed distant metastatic HNSCC, including but not limited to metastatic spread to the lungs, bones, or liver.
Active non-HNSCC malignancy.
Active pregnancy during treatment.

What this trial measures

  • 2 Years - Disease Free Survival (DFS)2 weeks after treatment completion

    2-year disease-free survival (DFS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion