Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma

Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.

This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.

PRIMARY OBJECTIVE:

I. To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC.

SECONDARY OBJECTIVES:

1. To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC.
2. To describe the association of quantitative ctDNA levels with time-to-event outcomes (overall survival (OS), disease-free survival (DFS), and time to recurrence (TTR)).
3. To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume.

OUTLINE:

Participants will have tissue samples collected at screening and blood samples collected for analysis before, during, and after non-investigational, standard of care treatment for cancer for up to 2 years

Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.
2. Participants must be age >=18 years.
3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
4. Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).