RecruitingNCT06606028

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.

Sponsor

University of California, San Francisco

Enrollment

250 participants

Start Date

Oct 9, 2024

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a sensitive blood test that detects cancer DNA fragments — called circulating tumor DNA (ctDNA) — can track remaining disease (minimal residual disease or MRD) after treatment for squamous cell carcinoma of the head, neck, or skin. The goal is to catch any leftover cancer that cannot be seen on imaging. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with squamous cell carcinoma of the head, neck, or skin (confirmed by biopsy) - You are planning to have curative-intent surgery or radiation treatment - You are willing and able to give written informed consent **You may NOT be eligible if...** - You have a medical reason you cannot safely have repeated blood draws (up to 300 mL total across 15 visits) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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