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.
University of California, San Francisco
250 participants
Oct 9, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.
- 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 Criteria1
- \. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).
Interventions
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
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 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06606028