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)
Conditions
Keywords
ctDNA
Brief 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
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
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
Sponsors
Haystack Oncology, Inc.
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin. 2. Participants must be age \>=18 years. 3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment. 4. Participants must have the ability to understand and the willingness to sign a written informed consent document.
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence rate of ctDNA | Up to 2 years | Cumulative incidence will be estimated by evaluating the cumulative incidence of positive ctDNA (non-zero) with death as a competing risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants at diagnosis with a positive (non-zero) ctDNA result. | Up to 2 years | 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) | Up to 2 years | 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) | Up to 2 years | 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) | Up to 2 years | 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. |
| Association of quantitative ctDNA levels with follow-up imaging tumor volume. | Up to 2 years | 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. |
Countries
United States
Contacts
Primary ContactSonia Contreras Martinez
Outcome results
None listed