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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05321784
Recruitment Status : Not yet recruiting
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Joanna Ludzik, MD, PhD, OHSU Knight Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Skin Cancer Melanoma Malignant Skin Neoplasm Device: Skin Examination Procedure: Skin Examination Other: Survey Administration Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2004 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: At-Home Dermoscopy Artificial Intelligence for Optimizing Early Triage of Skin Cancer
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: Group I (smartphone dermatoscope)
Patients perform self-skin exams using naked-eye criteria and smartphone dermatoscope at home for 4 months.
Device: Skin Examination
Perform self-skin exam using smartphone dermatoscope

Other: Survey Administration
Ancillary studies

Active Comparator: Group II (naked-eye skin exam)
Patients perform self-skin exams using naked-eye criteria at home for 6 months.
Procedure: Skin Examination
Perform self-skin exam

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Engagement [ Time Frame: At 4 months after first day of enrollment ]
    Engagement will be measured by the average number of self-reported self-skin exams (SSE) by participant for each group using a RedCap survey at the end of study at 4 months. Will be estimated with two-sided 95% confidence intervals.


Secondary Outcome Measures :
  1. Total number of suspicious lesions identified [ Time Frame: Up to 4 months after first day of enrollment ]
    The total number of suspicious lesions identified in both groups at the end of 4 months. All suspicious lesions will be reviewed by an expert dermoscopist(s) to determine how many were correctly identified as qualified for triage number needed to triage (NNT).

  2. Total number of biopsied lesions [ Time Frame: Up to 4 months after first day of enrollment ]
    All properly qualified suspicious lesions will be compared to final pathology reports, the denominator being a diagnosis of atypical nevus, melanoma in-situ, melanoma, or non-melanoma skin cancer. Sensitivity of correct triage will be determined by using any of the above pathology diagnosis (excluding a benign melanocytic nevus without the word atypical or unusual in the diagnosis title).

  3. Average diameter of correctly biopsied lesions [ Time Frame: Up to 4 months after first day of enrollment ]
    The number of atypical nevi, melanoma in-situ, melanoma and non-melanoma skin cancer with a diameter < 6 mm will be used as a success measure. Will be estimated with two-sided 95% confidence intervals, and compared using a two-sample t-test.

  4. Average Breslow depth of biopsied melanomas [ Time Frame: Up to 4 months after first day of enrollment ]
    The average Breslow depth of biopsied melanomas in both groups at the end of 4 months. Will be estimated with two-sided 95% confidence intervals, and compared using a two-sample t-test.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321784


Contacts
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Contact: Elizabeth Stoos 503-418-9356 stoos@ohsu.edu

Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Contact: Elizabeth Stoos    503-418-9356    stoos@ohsu.edu   
Principal Investigator: Joanna Ludzik, M.D.,Ph.D.         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
Investigators
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Principal Investigator: Joanna Ludzik, M.D.,Ph.D. OHSU Knight Cancer Institute
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Responsible Party: Joanna Ludzik, MD, PhD, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT05321784    
Other Study ID Numbers: STUDY00023727
NCI-2021-13411 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases