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Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients (IMAGE)

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ClinicalTrials.gov Identifier: NCT04385732
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : December 3, 2021
Sponsor:
Collaborators:
Monash University
University of Sydney
The University of Queensland
Information provided by (Responsible Party):
Melanoma and Skin Cancer Trials Limited

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.


Condition or disease Intervention/treatment Phase
Melanoma Skin Cancer Anxiety and Fear Device: 2D or 3D Melanoma Surveillance Photography Not Applicable

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 accuracy, 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. Test 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
    4. Is cost effective compared with a strategy of no MSP
  2. Estimate the financial implications to Medicare of introducing MSP
  3. Evaluate diagnostic accuracy of tele-dermatology compared to en-face clinical visits.
  4. Evaluate the safety and acceptability of melanoma surveillance photography

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 accuracy. Pre-specified secondary outcomes will be sensitivity and specificity, thickness and stage at diagnosis of subsequent melanomas, quality of life, costs and cost-effectiveness.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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.
Device: 2D or 3D Melanoma Surveillance Photography
Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.

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



Primary Outcome Measures :
  1. Diagnostic accuracy of Melanoma Surveillance Photography (MSP) [ Time Frame: 24 months ]

    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.



Secondary Outcome Measures :
  1. Cost-effectiveness of MSP [ Time Frame: 24 months ]
    Standard health economic cost-effectiveness measures.

  2. Diagnostic accuracy for melanoma [ Time Frame: 24 months ]
    Agreement and reliability indices.

  3. Diagnostic accuracy for keratinocyte lesions [ Time Frame: 24 months ]
    Agreement and reliability indices.

  4. Health-Related Quality of life [ Time Frame: 24 months ]
    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.

  5. Patient anxiety [ Time Frame: 24 months ]
    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).


Other Outcome Measures:
  1. IMAGE Sub-study 1: PRE-TRIAL EXCISION RATES [ Time Frame: 5 year (retrospective) ]
    To assess benefit of MSP in high-risk patients who have not yet had a melanoma, this study will compare Breslow thickness of the primary melanoma and excision rates prior to diagnosis amongst participants who would have been classified as 'high-risk' and who were under surveillance with MSP to those under surveillance without MSP prior to their melanoma diagnosis.

  2. IMAGE Sub-study 2: TELEDIAGNOSIS VALIDATION [ Time Frame: Validity analysis undertaken at a single time point based on data accrued over 24 month study period. ]
    Approximately 100 paired sets of baseline and surveillance images taken from patients in the intervention arm, will be sent to 10 participating study doctors (both GPs and dermatologists) for teledermatology assessment. Images will be selected randomly for this telediagnosis validation study. Approximately 30% of these will include an image of a melanoma confirmed by histopathology during the trial. This substudy will not affect patient care but will assess diagnostic accuracy (sensitivity and specificity) in the teledermatology setting compared to the en-face clinical setting in order to validate the use of telediagnosis in routine care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 6 months (186 days) 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 first 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 surveillance with TBP with tagged digital dermoscopy 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 surveillance with TBP (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. Stage IV metastatic melanoma
  2. Ocular melanoma, mucosal melanoma
  3. Melanoma of unknown primary site
  4. Cutaneous melanoma metastases
  5. Previous melanoma
  6. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385732


Contacts
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Contact: Victoria Mar +61 3 9076 0365 victoria.mar@monash.edu
Contact: Melanoma and Skin Cancer Trials Coordinator +61 3 9903 9022 image@masc.org.au

Locations
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Australia, New South Wales
Newcastle Skin Check Recruiting
Newcastle, New South Wales, Australia, 2290
Contact: Loren Golledge    (02) 4032 8700    info@newcastleskincheck.com.au   
Principal Investigator: Dr Anthony Azzi         
Australia, Queensland
Diamantina Institute, University of Queensland Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Kate Nufer    (07) 3443 7481    k.nufer@uq.edu.au   
Principal Investigator: Prof Peter Soyer         
FNQH Cairns Skin Cancer Centre Recruiting
Cairns, Queensland, Australia, 4870
Contact: Tarlia Rajeswaran    (07) 4040 5800    management@fnqh.com.au   
Principal Investigator: Dr Vinodh Rajeswaran         
Australia, Victoria
Skin Health Institute Recruiting
Carlton, Victoria, Australia, 3053
Contact: Sarah Chivers    (03) 9623 9465    schivers@skinhealthinstitute.org.au   
Principal Investigator: A/Prof Peter Foley         
Victorian Melanoma Service, Alfred Health Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jane Brack    (03) 9076 0816    vmstrials@alfred.org.au   
Principal Investigator: A/Prof Victoria Mar         
Bass Coast Health, Wonthaggi Recruiting
Wonthaggi, Victoria, Australia, 3995
Contact: Maree McFarlane    (03) 5671 3353    aree.McFarlane@basscoasthealth.org.au   
Principal Investigator: Dr Renee Kelsall         
Sponsors and Collaborators
Melanoma and Skin Cancer Trials Limited
Monash University
University of Sydney
The University of Queensland
Investigators
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Principal Investigator: Victoria Mar Monash University and Alfred Health
Additional Information:
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Responsible Party: Melanoma and Skin Cancer Trials Limited
ClinicalTrials.gov Identifier: NCT04385732    
Other Study ID Numbers: 02.19
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melanoma and Skin Cancer Trials Limited:
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
Additional relevant MeSH terms:
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Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases