Suspended

Assessment of Clinical Images, Digital Dermoscopy and Confocal Microscopy for Melanoma Screening

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Study Aim

This study aims to evaluate the sensitivity and specificity of clinical images, digital dermoscopy, and confocal microscopy in identifying melanoma, helping to improve the accuracy of melanoma screening.

What is being tested

Confocal Microscopy

+ Dermoscopy

+ Imaging Procedure

OtherProcedureDrug
Who is being recruted

Melanoma+11

+ Neoplasms

+ Neoplasms by Histologic Type

From 18 to 80 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: May 2018
See protocol details

Summary

Principal SponsorOHSU Knight Cancer Institute
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 18, 2018

Actual date on which the first participant was enrolled.

This study focuses on finding better ways to screen and diagnose melanoma, a type of skin cancer. It aims to evaluate the usefulness of different imaging techniques such as clinical images, digital dermoscopy images, and in-vivo confocal microscopy for teledermatology, a method of remote healthcare. The study involves individuals with suspicious moles. The goal is to improve the current triage system by incorporating these imaging technologies, which could potentially enhance patient care and address the challenges of melanoma detection. Participants in this study will have their suspicious moles imaged using a smartphone application, digital dermoscopy, and confocal microscopy. After the imaging, they will receive a local anesthetic called lidocaine and undergo a shave or punch biopsy of the suspected melanomas. The results of these imaging techniques will be compared to the biopsy results to determine their accuracy. Participants will be followed up within a week after the study intervention. The study measures the sensitivity and specificity of these imaging modalities, which means how well they can correctly identify melanomas and non-melanomas. The collected data will be analyzed to generate hypotheses for future studies.

Official TitleImaging Modalities for Melanoma Screening and Diagnosis
NCT03699995
Principal SponsorOHSU Knight Cancer Institute
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevusNevus, PigmentedSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

8 inclusion criteria required to participate
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.

Show More Criteria

1 exclusion criteria prevent from participating
Allergy to the anesthetic (lidocaine).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sancy Leachman

Portland, United StatesOpen Sancy Leachman in Google Maps
SuspendedOne Study Center
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