Melanoma Clinical Trial

At-Home Dermoscopy Artificial Intelligence for Optimizing Early Triage of Skin Cancer

Summary

This clinical trial is to find out whether having access to an at-home smartphone dermatoscope (medical grade device) improves a patient's ability to find concerning moles themselves at-home with artificial intelligence unlimited mole scanning. Traditionally, patients were only able to identify moles that may be suspicious for cancer based off current ABCD guidelines, however these guidelines are still limited to what the patient can easily see with the naked-eye. Using the current ABCD guidelines, patients may still miss skin cancers that are still in its early stages. New devices may allow patients to look at their moles microscopically with their smartphones. The moles can then be scanned by artificial intelligence that will inform the patient whether or not the mole is suspicious. New technology development may help explore ways patients can use these new tools to be more involved in their skin health, especially for those in high-risk populations and limited access to see a dermatologist.

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Full Description

PRIMARY OBJECTIVE:

I. To assess whether having access to at-home dermoscopy with mole scanning artificial intelligence increases skin self-screening engagement

SECONDARY OBJECTIVES:

I. To assess whether having access to at-home dermoscopy with mole scanning artificial intelligence improves triage of suspicious skin lesions II. To assess whether having access to at-home dermoscopy with mole scanning artificial intelligence improves identification of suspicious skin lesions III. To assess whether having access to at-home dermoscopy with mole scanning artificial intelligence leads to earlier detection of suspicious skin lesions IV. To assess whether having access to at-home dermoscopy with mole scanning artificial intelligence improves detection of thin melanomas

OUTLINE: Patients are randomized in 1 of 2 groups.

GROUP I: Patients perform self-skin exams using naked-eye criteria and smartphone dermatoscope at home for 6 months.

GROUP II: Patients perform self-skin exams using naked-eye criteria at home for 6 months.

View Eligibility Criteria

Eligibility Criteria

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 dermatology lesion/mole. Both men and women and members of all races and ethnic groups will be included.
Participants must be members of the Oregon Health and Science University (OHSU) melanoma community registry (IRB# 10561) or an OHSU patient.
Participants must have histologically confirmed previous diagnosis of melanoma, non-melanoma skin cancer without history of melanoma, or no prior history of skin cancer depending on their respective group.
Criteria for selected cutaneous malignancies can be found in the following references: J Laryngol Otol;130(S2):S125-S132, 2016 (non-melanoma skin cancer); J Clin Oncol;27(36):6199-206, 2009 (melanoma).
Participants must have access to a smartphone and be willing to set up MyChart.
Participants must be English-speaking or have access to an English-speaking translator.

Exclusion Criteria:

Participants who have had a MyChart encounter, e-visit or in-person visit related to a skin spot check or full body skin exam within the last 30 days will be excluded in order to avoid bias.
Vulnerable populations including children, prisoners, and decisional impaired adults, will not be eligible for this study. Pregnant individuals will be excluded in this study. Since this is a minimal pregnancy risk category, no special precautions will be taken to determine that the patient is not pregnant.

Study is for people with:

Melanoma

Estimated Enrollment:

504

Study ID:

NCT05321784

Recruitment Status:

Not yet recruiting

Sponsor:

OHSU Knight Cancer Institute

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There is 1 Location for this study

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OHSU Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Elizabeth Stoos
Contact
503-418-9356
[email protected]
Joanna Ludzik, M.D.,Ph.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

504

Study ID:

NCT05321784

Recruitment Status:

Not yet recruiting

Sponsor:


OHSU Knight Cancer Institute

How clear is this clinincal trial information?

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