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

Study acronym: IMAGE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 2025 to May 2025v10
  2. Completion date: Feb 2025 to May 2025v9
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 580 to confirmed 670 · Site details revised at 12 of 12 sitesv8 Show 2 more changesShow less
    • Enrollment target: estimated 580 to confirmed 670
    • Site details revised at 12 of 12 sites
  4. Primary completion date: Jun 2024 to Feb 2025 Completion date: Jul 2024 to Feb 2025v7 Show 1 more changeShow less
    • Completion date: Jul 2024 to Feb 2025
  5. Study sites: 10 to 12v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 8 to 10v5
  2. Primary endpoint revised Enrollment target: 680 to 580 · Study sites: 6 to 8 · Eligibility criteria expanded, about 138 words · 2 morev4 Show 5 more changesShow less
    • Enrollment target: 680 to 580
    • Study sites: 6 to 8
    • Eligibility criteria expanded, about 138 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 30 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jun 2023 to Jun 2024 · Study sites: 1 to 6 · Completion date: Jul 2023 to Jul 2024 · 3 morev3 Show 6 more changesShow less
    • Primary completion date: Jun 2023 to Jun 2024
    • Study sites: 1 to 6
    • Completion date: Jul 2023 to Jul 2024
    • Start date changed from estimate of Apr 2021 to Mar 3, 2021
    • Eligibility criteria expanded, about 89 words
    • Collaborators: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Aug 2020 to Apr 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04385732
Lead Sponsor Melanoma and Skin Cancer Trials Limited
Collaborators: Monash University, University of Sydney, The University of Queensland
Conditions Melanoma, Skin Cancer, Anxiety and Fear
Enrollment 670 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov