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

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 patients who will remain disease-free (those who are MRD negative). The hypothesis is that patients who have detectable ctDNA following treatment-MRD positive patients-will experience recurrent disease within 2 years, while patients who have no detectable ctDNA-MRD negative patients-will remain disease free at 2 years.
2. That measuring MRD after completion of curative-intent treatment will provide a lead time from detectable to clinical diagnosis of recurrent disease of at least 3 months.

The primary outcome is 2-year DFS in patients with detectable vs no detectable ctDNA two weeks after treatment completion.

The study will accrue 75 patients, who will be followed for a minimum of 2 years.

Subjects will have blood draws before, during and following treatment at regular intervals for testing with the assay (Haystack MRD™)