NCT06744296

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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™)

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
OTHER	Blood Draws and Tissue Sample(s)	All participants on the study, regardless of arm, will be getting blood draws, and tissue samples.

Timeline

• Start date: 2025-02-03
• Primary completion: 2027-01-06
• Completion: 2029-01-06
• First posted: 2024-12-20
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States