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: 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
Study Type
OBSERVATIONAL
Enrollment
250
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
University of California, San Francisco
San Francisco, California, United States
RECRUITINGCumulative 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.