NCT05321784 | RECRUITING | Malignant Skin Neoplasm

Detailed Description:

PRIMARY OBJECTIVE: I. The Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals\* for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is recommended in the pathologist management comment) (≥95% sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity). EXPLORATORY OBJECTIVES: I. To compare the accuracy of Sklip System triage when used by a layperson versus near-perfect Sklip System user II. To assess whether Sklip System improves triage of pigmented skin lesions of concern \< 6mm in diameter as suspicious as compared to the current medical provider virtual triage method that relies on store-and-forward non-medical-device assisted smartphone clinical images III. To assess whether Sklip System improves triage of thin melanomas with \< 0.8 mm Breslow depth as suspicious as compared to the current medical provider virtual triage method that relies on store-and-forward non-medical-device assisted smartphone clinical images IV. To determine the accuracy of layperson-performed self-skin-exam(s) at-home in the identification of all suspicious pigmented skin lesions of concern present on their body as compared to the same layperson evaluated with full body skin examination by a dermatology Provider in-office OUTLINE: This is a single-arm prospective trial. Participants perform self-skin exams using naked-eye criteria and will take smartphone clinical images (SCI) of each PSL of concern (PSLC). Participants will also take digital dermoscopy images (DDIs) and apply the Sklip System to each PSLC of concern in up to 14 days. Within up to 28 days of completing the at-home exams, participants will undergo an in-office visit full body skin exam (FBSE).