Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.
University of California, San Francisco
Summary
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.
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: 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 ti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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).
Interventions
- ProcedureBlood Specimen Collection
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
- ProcedureTumor Tissue Collection
Formalin-fixed paraffin embedded tumor tissue samples (tissue blocks of 12 x 10 millimeter (mm) unstained slides) derived from biopsy or surgical resection will be collected at screening
- OtherMedical Record Review
Medical records will be reviewed to collect standard of care p16 staining by immunohistochemistry and/or high-risk human papillomavirus (HPV) DNA or RNA testing that is performed as part of standard of care
Location
- University of California, San FranciscoSan Francisco, California