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

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new blood test designed to help doctors find out if certain patients with head and neck cancer are at risk of their cancer coming back after they have received treatment. This test looks for tiny pieces of cancer DNA in the blood, which can give important information about the patient's condition. The goal is to see if this personalized blood test can effectively predict cancer recurrence in patients who have had surgery or chemoradiotherapy for their cancer.

To participate in the trial, patients must be newly diagnosed with advanced stages (III-IVB) of squamous cell carcinoma of the head and neck and must be planning to receive standard treatment at specific hospitals in Massachusetts. Participants should be between 65 and 74 years old and have not received other cancer treatments before joining the study. During the trial, participants will undergo regular blood tests to monitor their cancer status. This study is currently recruiting, so eligible patients can get involved and contribute to important research that may improve cancer care in the future.

Gender

ALL

Eligibility criteria

• 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.