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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.
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.
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 belowSelect...
I speak English.
Select...
I am 21 or older and have at least one mole on my body.
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
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 moreTrial 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).
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Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,416 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,845,719 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."
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