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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03699995
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	OHSU Knight Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joanna Ludzik, MD
Principal Investigator Affiliation	OHSU Knight Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Melanoma, Melanocytic Nevus, Skin Carcinoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Screening (imaging, biopsy)

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.

Interventions

Other: - Confocal Microscopy

Undergo confocal microscopy

Other: - Dermoscopy

Undergo digital dermoscopy

Procedure: - Imaging Technique

Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone

Drug: - Lidocaine

Given SC

Procedure: - Punch Biopsy

Undergo punch biopsy

Procedure: - Shave Biopsy

Undergo shave biopsy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OHSU Knight Cancer Institute, Portland, Oregon

Status

Recruiting

Address

OHSU Knight Cancer Institute

Portland, Oregon, 97239

Site Contact

Joanna Ludzik, MD

[email protected]

503-418-3376

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