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

NCT ID: NCT03699995

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2026-12-31

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.

Conditions

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Cutaneous Melanoma Melanocytic Nevus Skin Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Confocal Microscopy

Intervention Type OTHER

Undergo confocal microscopy

Dermoscopy

Intervention Type OTHER

Undergo digital dermoscopy

Imaging Procedure

Intervention Type PROCEDURE

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

Lidocaine

Intervention Type DRUG

Given SC

Punch Biopsy

Intervention Type PROCEDURE

Undergo punch biopsy

Shave Biopsy

Intervention Type PROCEDURE

Undergo shave biopsy

Interventions

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Confocal Microscopy

Undergo confocal microscopy

Intervention Type OTHER

Dermoscopy

Undergo digital dermoscopy

Intervention Type OTHER

Imaging Procedure

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

Intervention Type PROCEDURE

Lidocaine

Given SC

Intervention Type DRUG

Punch Biopsy

Undergo punch biopsy

Intervention Type PROCEDURE

Shave Biopsy

Undergo shave biopsy

Intervention Type PROCEDURE

Other Intervention Names

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Confocal Laser Scanning Microscopy Diagnostic Imaging Technique Imaging Imaging Procedures Imaging Technique imaging type imaging_type Medical Imaging .omega.-Diethylamino-2,6-dimethylacetanilide 2-(Diethylamino)-2',6'-acetoxylidide Cuivasil Duncaine Leostesin Lidothesin Lignocaine Rucaina Punch Biopsy of Skin

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 sex can be enrolled.
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Sancy A Leachman, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanna Ludzik, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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Sancy Leachman

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sancy Leachman, MD, PhD

Role: CONTACT

Phone: 503-494-4713

Email: [email protected]

Facility Contacts

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Sancy Leachman, MD, PhD

Role: primary

Khoa Nguyen

Role: backup

Other Identifiers

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NCI-2018-01152

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00018408

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00018408

Identifier Type: -

Identifier Source: org_study_id