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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Blood Draws and Tissue Sample(s)

Treatment groups

75 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts Eye and Ear Infirmary

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Haystack Oncology, Inc.

Collaborator