Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck
Massachusetts Eye and Ear Infirmary
Summary
This study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment.
Description
This is a two-arm, prospective, observational study of patients with human papillomavirus (HPV)-independent head and neck squamous cell carcinoma (HNSCC) who are receiving curative-intent treatment. Arm 1 will consist of patients who undergo surgery. Arm 2 will consist of patients who undergo chemoradiotherapy. The study will test the following hypotheses: 1. That applying a tumor-informed minimal residual disease (MRD) assay after completion of curative-intent treatment will accurately discriminate between patients who will eventually experience recurrence (those are MRD positive) and patie…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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). E…
Interventions
- OtherBlood Draws and Tissue Sample(s)
All participants on the study, regardless of arm, will be getting blood draws, and tissue samples.
Location
- Massachusetts Eye and EarBoston, Massachusetts