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.
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.
None
Adult participants with squamous cell carcinoma of the head and neck mucosa and skin.
Cohort
Prospective
Blood Specimen Collection
Procedure/SurgeryApproximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
Tumor Tissue Collection
Procedure/SurgeryFormalin-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 Record Review
Other interventionMedical 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
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.
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.
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).
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).
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.
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University of California, San Francisco
Lead sponsor
Haystack Oncology, Inc.
Collaborator
