NCT06606028

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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

Conditions

• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
• Squamous Cell Carcinoma of Skin
• Cutaneous Squamous Cell Carcinoma (CSCC)

Interventions

Type	Name	Description
PROCEDURE	Blood Specimen Collection	Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
PROCEDURE	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
OTHER	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

Timeline

• Start date: 2024-10-09
• Primary completion: 2028-12-30
• Completion: 2029-12-30
• First posted: 2024-09-20
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States