Development and Validation of a Gene Expression Assay to Predict the Risk of Recurrence Disease in Cutaneous Squamous Cell Carcinoma
About
Non-melanoma skin cancer is the most common cancer in the United States. While basal cell carcinoma is the most common non-melanoma skin cancer, it rarely spreads (metastasizes) beyond the skin. The remaining non-melanoma skin cancers are primarily cutaneous squamous cell carcinomas (cSCC). While the metastatic rate in cutaneous squamous cell carcinoma overall is quite low, the rate increases to approximately 45% in certain groups of patients. As metastasis, and sometimes death, is the leading cause of added complications from cancer, figuring out the likelihood of a patient experiencing metastasis is very important.
Castle Biosciences, Inc. (CBI), has developed an investigational test that evaluates the biological nature of an individual patient’s tumor by using gene expression profiling to classify it as a low- or high-risk tumor. With this information, it is hoped that a doctor and patient can make important decisions together about treatment planning. This study is being done to further confirm the accuracy of this test in predicting the risk that a tumor will come back or spread to another part of the body.
Eligibility Criteria
Inclusion Criteria
- Patient with pathologically confirmed invasive cSCC diagnosed after January 1, 2017, and is under active follow-up
- Patient ≥18 years of age at time of diagnosis of cSCC lesion under study
- Patient able to provide informed consent
- Patients with more than one invasive cSCC must have all prior invasive cSCC tumors within three years, available for testing
- Patient likely to follow up with treating physician
Exclusion Criteria
- Patient who is immunosuppressed for any reason other than solid organ transplant, lymphoma/leukemia or HIV
- Patient whose primary tumor is not considered invasive (e.g. Bowen's disease) or definitively cSCC, for example, keratoacanthoma (KA; note: SCC KA-type is acceptable)
Primary Investigator
Kyle Prickett, M.D., is an assistant professor at the Virginia Tech Carilion School of Medicine. He earned his medical degree from the University of Maryland School of Medicine and completed his dermatology residency at Geisinger Medical Center, where he served as chief resident during his final year. He subsequently completed a fellowship in micrographic (Mohs) surgery and dermatologic oncology at Geisinger Medical Center. Dr. Prickett is certified by the American Board of Dermatology and is a member of the American College of Mohs Surgery.
Contact Information
Nicholas Joseph
Clinical Research Coordinator
