Overview
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 head and neck squamous cell carcinomas (HNC) after curative-intent primary radiation or surgery.
Description
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:
- To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC.
- 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)).
- 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
Eligibility
Inclusion Criteria:
- Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck.
- Participants must be age >=18 years.
- Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).