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NCT03699995 | RECRUITING | Cutaneous Melanoma

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

OHSU Knight Cancer Institute

Information provided by (Responsible Party):

Sancy A Leachman, MD, PhD

Brief Summary:

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.

Condition or disease

Cutaneous Melanoma

Melanocytic Nevus

Skin Carcinoma

Intervention/treatment

Confocal Microscopy

Dermoscopy

Imaging Procedure

Lidocaine

Punch Biopsy

Shave Biopsy

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Imaging Modalities for Melanoma Screening and Diagnosis
Actual Study Start Date : 2018-05-18
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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 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).
MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma

Location Details

NCT03699995

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Oregon

Sancy Leachman

Portland, Oregon, United States, 97239