MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma

Study Overview
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Brief Summary
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This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.

Detailed Description
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PRIMARY OBJECTIVE: I. To assess the clinical utility of clinical images, digital dermoscopy images and in-vivo confocal microscopy for teledermatology. SECONDARY OBJECTIVE: I. To incorporate in vivo confocal images into the triage system in order to determine to what degree the information gathered in this modality changes the classification of a lesion assigned by a licensed dermatologist. TERTIARY OBJECTIVE: I. To assess the potential improvement of virtual patient triage when adding digital dermoscopy images to clinical images presented by patients to their provider (via e-visit or e-consult). OUTLINE: Participants undergo imaging of suspicious moles via smartphone application (app) MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine subcutaneously (SC) and undergo shave or punch biopsy of suspected melanomas. After completion of study intervention, patients are followed up within 1 week.

Official Title
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Imaging Modalities for Melanoma Screening and Diagnosis

Conditions
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Cutaneous Melanoma, Melanocytic Nevus, Skin Carcinoma

Intervention / Treatment
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* Other: Confocal Microscopy
* Other: Dermoscopy
* Procedure: Imaging Technique
* Drug: Lidocaine
* Procedure: Punch Biopsy
* Procedure: Shave Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons who participate in the free skin cancer screening at the PDX Skincare Festival at Oregon Health & Science University (OHSU) in 2021/2022 (date pending) and are informed by a provider that they have a pigmented lesion for which a biopsy is recommended are potentially eligible to participate in this study. Persons who participate in the free skin cancer screening at the War on Skin Cancer event at OHSU in 2021/2022 (date pending) or other dates and locations and are informed by a provider that they have a clinically benign or atypical nevi are eligible to participate in the imaging portion of this study. No biopsy will be offered to these participants. Persons age 18-80 are eligible for the study Persons of any race are eligible but we anticipate that most participants will be Non-Hispanic whites due to the prevalence of melanoma and other skin cancers in this group. Only persons who can provide signed statement of informed consent will be enrolled. Persons who are identified in OHSU Dermatology clinics or through OHSU e-visit and e-consult platforms as having a skin lesion in need of a biopsy for skin cancer Persons identified via the Melanoma Community Registry (MCR) (IRB approved: 00010561) Exclusion Criteria: Allergy to the anesthetic (lidocaine).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (imaging, biopsy)<br>Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas. | Other: Confocal Microscopy<br>* Undergo confocal microscopy<br>* Other names: Confocal Laser Scanning Microscopy;Other: Dermoscopy<br>* Undergo digital dermoscopy<br>Procedure: Imaging Technique<br>* Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone<br>* Other names: Medical Imaging;Drug: Lidocaine<br>* Given SC<br>* Other names: Rucaina;Procedure: Punch Biopsy<br>* Undergo punch biopsy<br>* Other names: Punch Biopsy of Skin;Procedure: Shave Biopsy<br>* Undergo shave biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the imaging modalities | Sensitivity is defined as recommend immediate biopsy (red) lesions correctly identified as red by the dermatologists. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals. | Up to 1 year | 
| Specificity of imaging modalities | Specificity is defined as green (follow-up at annual skin exam) or yellow lesions (recommend examination by dermatologist in 3 months) correctly identified. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report | Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the VisioMed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined. | Up to 1 year | 
| Specificity by changes after consideration of RCM report | Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the Visiomed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined. | Up to 1 year |