Clinical trial NCT04385732: Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Official title: Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Melanoma and Skin Cancer Trials Limited
Sponsor class: OTHER
Collaborators: name: Monash University
name: University of Sydney
name: The University of Queensland
First posted: 2020-05-13
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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 diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts.

The secondary aims are to:

1. Evaluate whether MSP:

   1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
   2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
   3. Reduces costs to patients and health care system
2. Evaluate the safety and acceptability of MSP
3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2).

Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to:

1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
3. Improved quality of life; and
4. Favourable health economic outcomes.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance of melanoma surveillance
timeFrame: 24 months
Secondary outcomes:
measure: Cost-effectiveness of MSP
timeFrame: 24 months
measure: Diagnostic performance for melanoma
timeFrame: 24 months
measure: Diagnostic performance for keratinocyte lesions
timeFrame: 24 months
measure: Health-Related Quality of life
timeFrame: 24 months
measure: Patient anxiety
timeFrame: 24 months
Other outcomes:
measure: IMAGE Sub-study 1: PRE-TRIAL EXCISION RATES
timeFrame: 5 year (retrospective)
measure: IMAGE Sub-study 2: TELEDIAGNOSIS VALIDATION
timeFrame: Validity analysis undertaken at a single time point based on data accrued over 24 month study period.
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Newcastle Skin Check
state: New South Wales
city: Sydney
country: Australia
facility: Dermatology Clinical Trials Unit, Westmead Hospital
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Brisbane
country: Australia
facility: Diamantina Institute, University of Queensland
state: Queensland
city: Cairns
country: Australia
facility: FNQH Cairns Skin Cancer Centre
state: Queensland
city: Townsville
country: Australia
facility: Skin Repair Skin Cancer Clinic, Townsville
state: Queensland
city: Bendigo
country: Australia
facility: Bendigo Cancer Centre Research Unit, Bendigo Health
state: Victoria
city: Carlton
country: Australia
facility: Skin Health Institute
state: Victoria
city: Cowes
country: Australia
facility: Phillip Island Health Hub, Bass Coast Health
state: Victoria
city: Melbourne
country: Australia
facility: Victorian Melanoma Service, Alfred Health
state: Victoria
city: Wonthaggi
country: Australia
facility: Wonthaggi Hospital, Bass Coast Health
state: Victoria
Study officials:
affiliation: Monash University and Alfred Health
name: Victoria Mar
role: PRINCIPAL_INVESTIGATOR
References: