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AI-Assisted Smartphone Dermoscopy for Skin Cancer

N/A

Waitlist Available

Led By Sancy A. Leachman, MD, PhD

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first day of enrollment to 42 days after first day of enrollment

Awards & highlights

Study Summary

This trial is testing whether a smartphone dermatoscope can help patients find skin cancer early. The phone is equipped with AI that will scan the mole and tell the patient if it is cancerous.

Who is the study for?

This trial is for adults over 21 with at least one mole, who are not urgently sick. They must have skin types 1-4, speak English, be able to use a smartphone/tablet for communication and give consent. Excluded are those with recent skin checks, darker skin types (5-6), vulnerable groups like children or prisoners, vision impaired individuals, and pregnant people.Check my eligibility

What is being tested?

The Sklip System's ability to help non-professionals check moles at home is being tested against traditional medical evaluations. It aims to see if laypersons can accurately identify suspicious lesions needing biopsy and compares this method to virtual triage by medical providers using photos.See study design

What are the potential side effects?

Since the study involves non-invasive procedures like self-examinations and digital photography without direct physical interventions or medications, there are no expected side effects from participating in this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first day of enrollment to 42 days after first day of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first day of enrollment to 42 days after first day of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first day of enrollment to 42 days after first day of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Triage accuracy of the Sklip System using participant at-home digital dermoscopy image (DDI)

Secondary outcome measures

Biopsy

Average diameter of correctly biopsied lesions

Total number of biopsied lesions

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).Experimental Treatment6 Interventions

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 (integrating the Sklip Mole Scan Algorithm (SMSA) 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).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

231 Previous Clinical Trials

2,090,473 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

976 Previous Clinical Trials

7,385,959 Total Patients Enrolled

Sancy A. Leachman, MD, PhDPrincipal InvestigatorOHSU Knight Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently seeking participants?

"As indicated on clinicaltrials.gov, this research endeavour is not currently open for enrollment. It was first listed on February 1st 2023 and has most recently been amended November 3rd 2022. While no longer recruiting, there are a great many other investigation studies seeking participants at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

At-Home Dermoscopy Artificial Intelligence

Sancy A Leachman, MD, PhD 2024. "At-Home Dermoscopy Artificial Intelligence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05321784.