TerminatedNot Applicable

At-Home Dermoscopy Artificial Intelligence

Stopped: Inadequate enrollment

United States1 participantsStarted 2023-09-27

Plain-language summary

This is a new protocol to analyze how the use of 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 the detection of PSLCs that require biopsy (Melanoma and atypical melanocytic nevi with uncertain malignant, Squamous cell carcinoma, Basal cell carcinoma). The study protocol will also compare the accuracy of the Sklip System when used by a layperson (Participant) versus near-perfect Sklip System user (Study Coordinator), assess whether Sklip System improves triage of PSLCs \< 6 mm in diameter and 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 of smartphone clinical images (SCI), and assess accuracy of layperson-performed self-skin-exams (SSEs) at-home in the identification of all suspicious PSLCs present on their body as compared to the same layperson (Participant) evaluated with a full body skin examination (FBSE) by a dermatology Provider (DP) in-person.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Participant or legally authorized representative (LAR) must provide written informed consent before any Study-specific procedures or interventions are performed.
✓. Age ≥ 21 years with at least one pigmented skin lesion (PSL)/mole on their body. All genders and members of all races and ethnic groups will be included.
✓. Participant self-identifies as having Fitzpatrick Skin Type 1 through 4.
✓. Participant must be a current or new patient through self-referral or Provider-referral at the participating Study Site.
✓. Participant must have access to a smartphone/tablet and be willing to set up virtual communication via direct message to a Study Site dermatology provider (i.e. MyChart in EPIC, direct message in ModMed EMA or other electronic medical record (EMR) type)
✓. Participant must be English-speaking due to FDA Breakthrough Designation of the Sklip System in the English language. Therefore, we are unable to accommodate non-English speaking Participants.
✓. Participant must be "Healthy", which is defined as someone considered not urgently sick or hospitalized. This will be determined by the Study principle investigator (PI) at each Study Site, a licensed dermatologist, who will be responsible for screening Participants to ensure eligibility criteria is met prior to enrollment.

Exclusion criteria

What they're measuring

Triage Accuracy of the Sklip System Using Participant At-home Digital Dermoscopy Image (DDI)

Timeframe: From first day of enrollment to 42 days after first day of enrollment

Trial details

NCT IDNCT05321784

SponsorOHSU Knight Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Results submitted2025-12-09

View on ClinicalTrials.gov More Malignant Skin Neoplasm trials