Abstract
Despite significant progress in the development of treatment options, melanoma remains a leading cause of death due to skin cancer. Advances in our understanding of the genetic, transcriptomic, and morphologic spectrum of benign and malignant melanocytic neoplasia have enabled the field to propose biomarkers with potential diagnostic, prognostic, and predictive value. While these proposed biomarkers have the potential to improve clinical decision making at multiple critical intervention points, most remain unvalidated. Clinical validation of even the most commonly assessed biomarkers will require substantial resources, including limited clinical specimens. It is therefore important to consider the properties that constitute a relevant and clinically-useful biomarker-based test prior to engaging in large validation studies. In this review article we adapt an established framework for determining minimally-useful biomarker test characteristics, and apply this framework to a discussion of currently used and proposed biomarkers designed to aid melanoma detection, staging, prognosis, and choice of treatment.
Highlights
At a fundamental level, clinical tests are designed to aid clinicians in determining a best course of action when there is clinical uncertainty
We summarize the established theoretical framework for determining the minimal test characteristics required to potentially alter clinical decision making at different stages of melanoma care
We touch upon similar analyses here, our goal is to review a larger spectrum of biomarkers for melanoma care—preliminary to practiced— from the perspective of prioritizing further development
Summary
Clinical tests are designed to aid clinicians in determining a best course of action when there is clinical uncertainty. These tests aim to improve certainty by ruling out a disease state, confirming a disease state, delineating prognosis, and/or identifying the most appropriate treatment regimen. Even a biomarker with an established disease state association may not be useful if it does not influence clinical decision-making. There are numerous factors that determine clinical utility: pre-test certainty of disease state, risks associated with making a clinical decision, cost, turn-around time, and the unique circumstances of each patient. From discovery to validation, requires substantial resources, investigators should carefully consider what characteristics are necessary for a useful clinical test at each stage of development
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