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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04385732




Registration number
NCT04385732
Ethics application status
Date submitted
1/04/2020
Date registered
13/05/2020
Date last updated
24/04/2023

Titles & IDs
Public title
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Scientific title
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Secondary ID [1] 0 0
02.19
Universal Trial Number (UTN)
Trial acronym
IMAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Skin Cancer 0 0
Anxiety and Fear 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 2D or 3D Melanoma Surveillance Photography

Experimental: Standard of Care plus Melanoma Surveillance Photography - Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.

No intervention: Standard of Care - Clinical surveillance standard of care without Melanoma Surveillance Photography.


Treatment: Devices: 2D or 3D Melanoma Surveillance Photography
Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic performance of melanoma surveillance
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Cost-effectiveness of MSP
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Diagnostic performance for melanoma
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Diagnostic performance for keratinocyte lesions
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Health-Related Quality of life
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Patient anxiety
Timepoint [5] 0 0
24 months

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
Accrual to date
Final
670
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Newcastle Skin Check - Newcastle
Recruitment hospital [3] 0 0
Dermatology Clinical Trials Unit, Westmead Hospital - Sydney
Recruitment hospital [4] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment hospital [5] 0 0
Diamantina Institute, University of Queensland - Brisbane
Recruitment hospital [6] 0 0
FNQH Cairns Skin Cancer Centre - Cairns
Recruitment hospital [7] 0 0
Skin Repair Skin Cancer Clinic, Townsville - Townsville
Recruitment hospital [8] 0 0
Bendigo Cancer Centre Research Unit, Bendigo Health - Bendigo
Recruitment hospital [9] 0 0
Skin Health Institute - Carlton
Recruitment hospital [10] 0 0
Phillip Island Health Hub, Bass Coast Health - Cowes
Recruitment hospital [11] 0 0
Victorian Melanoma Service, Alfred Health - Melbourne
Recruitment hospital [12] 0 0
Wonthaggi Hospital, Bass Coast Health - Wonthaggi
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2290 - Newcastle
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment postcode(s) [7] 0 0
4812 - Townsville
Recruitment postcode(s) [8] 0 0
3550 - Bendigo
Recruitment postcode(s) [9] 0 0
3053 - Carlton
Recruitment postcode(s) [10] 0 0
3922 - Cowes
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
3995 - Wonthaggi

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of Queensland
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04385732
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Victoria Mar
Address 0 0
Monash University and Alfred Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04385732