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Trial details imported from ClinicalTrials.gov

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




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

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
Cancer 0 0 0 0
Non melanoma skin cancer

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.

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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic accuracy of Melanoma Surveillance Photography (MSP) - Determine whether MSP will reduce the number of unnecessary biopsies performed during surveillance. Number of unnecessary excisions or 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).
Number needed to excise (NNE) to detect one melanoma.
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Cost-effectiveness of MSP - Standard health economic cost-effectiveness measures.
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Diagnostic accuracy for melanoma - Agreement and reliability indices.
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Diagnostic accuracy for keratinocyte lesions - Agreement and reliability indices.
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Health-Related Quality of life - Assessment of Quality of Life (AQOL-8D) questionnaire for calculation of quality-adjusted life years (QALYs). Minimum score per each of 8 questions is 1; maximum score is 5, where higher score represents worse outcomes. Scores may be aggregated to provide an overall index of the health state utility per participant, where higher scores indicate worse quality of life outcomes.
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Patient anxiety - European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Fear of Cancer Recurrence - short form (FCR4) and a purpose-designed patient acceptability scale will be utilised to synthesise a single endpoint measure for patient anxiety. Value range is 0 to 100, where higher values represent greater anxiety (worse outcomes).
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

2. Within 4 months of histologically confirmed first primary cutaneous melanoma (insitu
or invasive)

3. Able to provide informed consent, complete questionnaires, and attend trial site for
MSP*

4. Physically able to receive TBP*

5. High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix
IV)*

6. Multiple naevi*

7. Not previously under surveillance with MSP*

8. Living in Australia and not planning to move overseas within the next 3 years*
Minimum age
18 Years
Maximum age
No limit
Gender
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. Stage IV metastatic melanoma

2. Ocular melanoma, mucosal melanoma

3. Melanoma of unknown primary site

4. Cutaneous melanoma metastases

5. Previous melanoma

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

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

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 accuracy as measured by the number of unnecessary biopsies will
be the primary outcome measure.
Trial website
https://clinicaltrials.gov/show/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
Victoria Mar
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 0365
Fax 0 0
Email 0 0
victoria.mar@monash.edu
Contact person for scientific queries

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