Clinical trial NCT03699995: MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma
Official title: Imaging Modalities for Melanoma Screening and Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cutaneous Melanoma
Melanocytic Nevus
Skin Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2018-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility 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).

Primary outcomes:
measure: Sensitivity of the imaging modalities
timeFrame: Up to 1 year
measure: Specificity of imaging modalities
timeFrame: Up to 1 year
Secondary outcomes:
measure: Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report
timeFrame: Up to 1 year
measure: Specificity by changes after consideration of RCM report
timeFrame: Up to 1 year
Other outcomes:
measure: Improvements in virtual triage of patients when enabling patients to take and submit digital dermoscopy images from home
timeFrame: Up to 1 year
Locations:
city: Portland
country: United States
facility: Sancy Leachman
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Joanna Ludzik, MD
role: PRINCIPAL_INVESTIGATOR
References: