Blood test to detect cancer recurrence in head and neck patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a personalized blood test in predicting recurrence of HPV-independent head and neck squamous cell carcinoma (HNSCC) after curative-intent treatment. It involves two arms: one for patients undergoing surgery and another for those receiving chemoradiotherapy. The study will measure minimal residual disease (MRD) through ctDNA analysis to differentiate between patients who will experience recurrence and those who will remain disease-free. A total of 75 patients will be followed for at least two years, with blood samples collected at various intervals for testing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Massachusetts Eye and Ear
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Daniel Faden, MD — Massachusetts Eye and Ear
• Study coordinator: Michael Cheung, MSc, CCRP
• Email: mcheung0@meei.harvard.edu
• Phone: 617-573-6060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.