An observational study in Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) and Squamous Cell Carcinoma of Skin, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by University of California, San Francisco · Observational
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.
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:
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
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 179 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with squamous cell carcinoma of the head and neck mucosa and skin.
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).
Participants will have tumor tissue collected at screening and blood samples (approximately 20ml x 3) will be obtained during non-investigational, standard of care radiation and after care for up to 2 years.
Procedure: Blood Specimen Collection · Procedure: Tumor Tissue Collection · Other: Medical Record Review
Participants will have tumor tissue collected at screening and blood samples (approximately 20ml x 3) will be obtained during non-investigational, standard of care surgery and after care for up to 2 years.
Procedure: Blood Specimen Collection · Procedure: Tumor Tissue Collection · Other: Medical Record Review
Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
Also known as: Blood Specimen, Biospecimen 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
Also known as: Tissue Specimen, Biospecimen collection
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
Also known as: Chart Review
Cumulative incidence rate of ctDNA
Cumulative incidence will be estimated by evaluating the cumulative incidence of positive ctDNA (non-zero) with death as a competing risk.
Time frame: Up to 2 years
Proportion of participants at diagnosis with a positive (non-zero) ctDNA result.
The prevalence of detectable ctDNA at initial diagnosis in participants with locally-advanced head and neck cancer will be reported as the proportion of participants at diagnosis with a positive (non-zero) ctDNA result.
Time frame: Up to 2 years
Association of association of quantitative ctDNA levels with overall survival (OS)
The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with overall survival (OS).
Time frame: Up to 2 years
Association of association of quantitative ctDNA levels with disease-free survival (DFS)
The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with overall survival (OS).
Time frame: Up to 2 years
Association of association of quantitative ctDNA levels with time to recurrence (TTR)
The Pearson correlation coefficient (r) measures the strength and direction of association between two variables. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with TTR.
Time frame: Up to 2 years
Association of quantitative ctDNA levels with follow-up imaging tumor volume.
The Pearson correlation coefficient (r) measures the strength and direction of association between two variables. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with tumor volume.
Time frame: Up to 2 years
Plan to share: No — De-identified laboratory data will be shared with industry collaborators on this study only
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