Noninvasive Adhesive Biopsy for Skin Lesions

This trial explores a new, noninvasive method to examine suspicious skin spots in children using a special adhesive patch (DermTech PLA noninvasive adhesive biopsy). The goal is to determine if this method can predict whether a spot is harmful before opting for a surgical biopsy. The trial specifically seeks children and teens with unusual skin spots that might require monitoring or removal soon. As a Phase 1 trial, the research focuses on understanding how this innovative method works in people, offering participants the opportunity to be among the first to benefit from this new approach.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that the DermTech Pigmented Lesion Assay (PLA) safely checks skin spots using a simple adhesive patch. This patch collects skin cells without cutting the skin, unlike a surgical biopsy. Studies have found that it accurately identifies suspicious spots.

In a study of 3,418 skin spots, the PLA correctly identified 95% of spots with disease and 91% of spots without disease, demonstrating its reliability and safety.

Unlike the standard of care for evaluating skin lesions, which typically involves surgical biopsies, the DermTech PLA noninvasive adhesive biopsy offers a less invasive alternative. This method involves simply pressing an adhesive over the lesion to collect superficial skin cells, eliminating the need for cutting into the skin. Researchers are excited about this approach because it reduces discomfort and potential complications associated with surgical biopsies, while still providing valuable diagnostic information. Additionally, this noninvasive technique could streamline the diagnostic process, making it quicker and more accessible for patients.

Research has shown that the DermTech Pigmented Lesion Assay (PLA), used by participants in this trial, reliably detects suspicious skin spots. Studies indicate it correctly identifies melanoma in 95 out of 100 cases, demonstrating a sensitivity of 95%. It also accurately identifies non-cancerous spots 91% of the time, reflecting its high specificity. The test uses a simple sticky patch to collect skin cells, making it painless and non-invasive. Furthermore, a negative test result indicates a 99% chance that melanoma is not present. This evidence suggests it can help avoid unnecessary surgical biopsies while effectively detecting melanoma early.¹³⁶⁷⁸