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Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma
Sponsor: 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.
Official title: Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2024-10-09
Completion Date
2029-12-30
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
Blood Specimen Collection
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
Tumor 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
Medical 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
Locations (1)
University of California, San Francisco
San Francisco, California, United States