Status:
ACTIVE_NOT_RECRUITING
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Lead Sponsor:
Melanoma and Skin Cancer Trials Limited
Collaborating Sponsors:
Monash University
University of Sydney
Conditions:
Melanoma
Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 met...
Detailed Description
The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved dia...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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)
- Exclusion criteria
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT04385732
Start Date
March 3 2021
End Date
May 1 2025
Last Update
May 8 2025
Active Locations (12)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Newcastle Skin Check
Newcastle, New South Wales, Australia, 2290
3
Dermatology Clinical Trials Unit, Westmead Hospital
Sydney, New South Wales, Australia, 2145
4
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065