Clinical trial · Interventional
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety and Fear | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2D or 3D Melanoma Surveillance Photography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard of Care plus Melanoma Surveillance Photography
- description
- Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.
- interventionNames
- Device: 2D or 3D Melanoma Surveillance Photography
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Clinical surveillance standard of care without Melanoma Surveillance Photography.
Primary outcomes (1)
- measure
- Diagnostic performance of melanoma surveillance
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria Patients may be included in the study if they meet ALL of the following criteria: 1. Aged 18 years or older at date of diagnosis 2. 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) 3. Able to provide informed consent, complete questionnaires, and attend trial site for MSP\* 4. Appropriate for TBP referral 5. High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix IV)\* 6. Multiple naevi, as "some" or "many" naevi on pictogram below at Screening \& Baseline visit. 7. Not previously under active surveillance (at least yearly) with TBP for melanoma surveillance (see inclusion criteria 9) 8. Living in Australia and not planning to move overseas within the next 3 years 9. Participants that meet all eligibility criteria but have previously been under active surveillance with TBP for at least the previous 2 years meet exclusion critierion 1, in which case they are ineligible for the main study and eligible for sub-study 1 only. 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). 10. Patients need to have had at least annual surveillance over the past 2 years (at least) to be eligible for sub-study 1 (note that this refers to annual skin surveillance not annual TBP images being taken) (i.e. do not meet inclusion criteria 7 are eligible for sub-study 1) Exclusion criteria Patients will be excluded from the study for ANY of the following reasons: 1. Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma 2. Stage IV metastatic melanoma 3. Ocular melanoma, mucosal melanoma 4. Participation in another clinical trial or study involving MSP Note: A past history of other cancers is not an exclusion criteria. \*These eligibility criteria cannot be assessed by the cancer registry. These criteria will be assessed by the study team and/or referring doctor.
References
Publications (1)
- DERIVEDYan 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