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

NCT04385732 | Active Not Recruiting

• 1 other identifier: 02.19
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 12

Brief 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

Melanoma; Skin Cancer; Anxiety and Fear

Keywords

Dermatology; Teledermatology; 2D Total Body Imaging; 3D Total Body Imaging; Melanoma Surveillance Photography; Biopsy; Excision; Health-related Quality of Life; Health system utilisation; Health economics

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of melanoma surveillance

  The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.

  24 months

Secondary Outcomes (5)

• Cost-effectiveness of MSP

  24 months

• Diagnostic performance for melanoma

  24 months

• Diagnostic performance for keratinocyte lesions

  24 months

• Health-Related Quality of life

  24 months

• Patient anxiety

  24 months

Other Outcomes (2)

• IMAGE Sub-study 1: PRE-TRIAL EXCISION RATES

  5 year (retrospective)

• IMAGE Sub-study 2: TELEDIAGNOSIS VALIDATION

  Validity analysis undertaken at a single time point based on data accrued over 24 month study period.

Study Arms (2)

Standard of Care plus Melanoma Surveillance Photography

EXPERIMENTAL

Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.

Device: 2D or 3D Melanoma Surveillance Photography

Standard of Care

NO INTERVENTION

Clinical surveillance standard of care without Melanoma Surveillance Photography.

Interventions

2D or 3D Melanoma Surveillance Photography DEVICE

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

Standard of Care plus Melanoma Surveillance Photography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be included in the study if they meet ALL of the following criteria:
• Aged 18 years or older at date of diagnosis
• Within 24 months (2 years) of the date of diagnosis when attending Screening \& Baseline Visit: where date of diagnosis refers to the date on the pathology report that provides histological confirmation of primary cutaneous melanoma (insitu or invasive)
• Able to provide informed consent, complete questionnaires, and attend trial site for MSP\*
• Appropriate for TBP referral
• High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix IV)\*
• Multiple naevi, as "some" or "many" naevi on pictogram below at Screening \& Baseline visit.
• Living in Australia and not planning to move overseas within the next 3 years
• Active surveillance with TBP refers to TBP images having been taken AND used for melanoma surveillance. As such, if a patient had TBP but these images were not used for melanoma surveillance (i.e. not used by clinicians to monitor a patient's skin), then surveillance is not considered active and the patient would still be eligible for the main study (as well as sub-study 1).

You may not qualify if:

• Patients will be excluded from the study for ANY of the following reasons:
• Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma
• Stage IV metastatic melanoma
• Ocular melanoma, mucosal melanoma
• Participation in another clinical trial or study involving MSP
• Note:
• \*These eligibility criteria cannot be assessed by the cancer registry. These criteria will be assessed by the study team and/or referring doctor.

Sponsors & Collaborators

• Melanoma and Skin Cancer Trials Limited: lead
• Monash University: collaborator
• University of Sydney: collaborator
• The University of Queensland: collaborator

Study Sites (12)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Newcastle Skin Check

Newcastle, New South Wales, 2290, Australia

Location

Dermatology Clinical Trials Unit, Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Melanoma Institute Australia

Wollstonecraft, New South Wales, 2065, Australia

Location

Diamantina Institute, University of Queensland

Brisbane, Queensland, 4102, Australia

Location

FNQH Cairns Skin Cancer Centre

Cairns, Queensland, 4870, Australia

Location

Skin Repair Skin Cancer Clinic, Townsville

Townsville, Queensland, 4812, Australia

Location

Bendigo Cancer Centre Research Unit, Bendigo Health

Bendigo, Victoria, 3550, Australia

Location

Skin Health Institute

Carlton, Victoria, 3053, Australia

Location

Phillip Island Health Hub, Bass Coast Health

Cowes, Victoria, 3922, Australia

Location

Victorian Melanoma Service, Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Wonthaggi Hospital, Bass Coast Health

Wonthaggi, Victoria, 3995, Australia

Location

Related Publications (1)

• Yan MK, Cust AE, Soyer HP, Janda M, Loewe K, Byars G, Fishburn P, White P, Mahumud RA, Saw RPM, Herschtal A, Fernandez-Penas P, Guitera P, Morton RL, Kelly J, Wolfe R, Mar VJ. Study protocol for a randomised controlled trial to evaluate the use of melanoma surveillance photography to the Improve early detection of MelanomA in ultra-hiGh and high-risk patiEnts (the IMAGE trial). Trials. 2023 Mar 29;24(1):236. doi: 10.1186/s13063-023-07203-5.

  PMID: 36991460 DERIVED

Related Links

• Detailed information on the IMAGE trial

MeSH Terms

Conditions

Melanoma; Skin Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Study Officials

• Victoria Mar

  Monash University and Alfred Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is an open-label, multi-site, parallel-arm randomised controlled trial. Participants meeting the eligibility criteria will be randomised 1:1 to either standard care or the intervention arm. Randomisation will be 1:1 to either Intervention or Control group stratified by high/ultra-high risk of 2nd primary melanoma, sex, 2D/3D imaging, GP/Dermatologist.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: May 13, 2020
• Study Start: March 3, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (12)