NCT04385732Active, not recruiting
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 670 (actual)
- First submitted
- 1 Apr 2020
- Start date
- 3 Mar 2021
- Primary completion date
- May 2025
- Lead sponsor
- Melanoma and Skin Cancer Trials Limited
- Diseases
- Melanoma
- NCT number
- NCT04385732
What you commit to
- Study type: Interventional
- Participants enrolled: 670
- From 3 Mar 2021 to the primary completion date, May 2025
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma
Other illness
- 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.
Other
- Patients will be excluded from the study for ANY of the following reasons:
- Stage IV metastatic melanoma
- Ocular melanoma, mucosal melanoma
Who the study is looking for
- 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.
- Not previously under active surveillance (at least yearly) with TBP for melanoma surveillance (see inclusion criteria 9)
- Living in Australia and not planning to move overseas within the next 3 years
- 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).
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bendigo Cancer Centre Research Unit, Bendigo Health Coordinator of this site? Confirm its status | Bendigo | Australia | Unknown status |
| Diamantina Institute, University of Queensland Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| FNQH Cairns Skin Cancer Centre Coordinator of this site? Confirm its status | Cairns | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Skin Health Institute Coordinator of this site? Confirm its status | Carlton | Australia | Unknown status |
| Phillip Island Health Hub, Bass Coast Health Coordinator of this site? Confirm its status | Cowes | Australia | Unknown status |
| Victorian Melanoma Service, Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Newcastle Skin Check Coordinator of this site? Confirm its status | Newcastle | Australia | Unknown status |
| Dermatology Clinical Trials Unit, Westmead Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Skin Repair Skin Cancer Clinic, Townsville Coordinator of this site? Confirm its status | Townsville | Australia | Unknown status |
| Melanoma Institute Australia Coordinator of this site? Confirm its status | Wollstonecraft | Australia | Unknown status |
| Wonthaggi Hospital, Bass Coast Health Coordinator of this site? Confirm its status | Wonthaggi | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.