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Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients

NCT04385732 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2025-05-08

No results posted yet for this study

Summary

This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.

It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.

Conditions

Interventions

DEVICE

2D or 3D Melanoma Surveillance Photography

Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • University of Sydney

    collaborator OTHER

  • The University of Queensland

    collaborator OTHER

  • Melanoma and Skin Cancer Trials Limited

    lead OTHER

Principal Investigators

  • Victoria Mar · Monash University and Alfred Health

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04385732 on ClinicalTrials.gov