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

Primary Purpose

Melanoma, Skin Cancer, Anxiety and Fear

Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
2D or 3D Melanoma Surveillance Photography
Sponsored by
Melanoma and Skin Cancer Trials Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Prince Alfred Hospital
  • Newcastle Skin Check
  • Dermatology Clinical Trials Unit, Westmead Hospital
  • Melanoma Institute Australia
  • Diamantina Institute, University of Queensland
  • FNQH Cairns Skin Cancer Centre
  • Skin Repair Skin Cancer Clinic, Townsville
  • Bendigo Cancer Centre Research Unit, Bendigo Health
  • Skin Health Institute
  • Phillip Island Health Hub, Bass Coast Health
  • Victorian Melanoma Service, Alfred Health
  • Wonthaggi Hospital, Bass Coast Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard of Care plus Melanoma Surveillance Photography

Standard of Care

Arm Description

Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.

Clinical surveillance standard of care without Melanoma Surveillance Photography.

Outcomes

Primary Outcome Measures

Diagnostic performance of melanoma surveillance
The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.

Secondary Outcome Measures

Cost-effectiveness of MSP
Standard health economic cost-effectiveness measures.
Diagnostic performance for melanoma
Agreement and reliability indices.
Diagnostic performance for keratinocyte lesions
Agreement and reliability indices.
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.
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).

Full Information

First Posted
April 1, 2020
Last Updated
April 20, 2023
Sponsor
Melanoma and Skin Cancer Trials Limited
Collaborators
Monash University, University of Sydney, The University of Queensland
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1. Study Identification

Unique Protocol Identification Number
NCT04385732
Brief Title
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Acronym
IMAGE
Official Title
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melanoma and Skin Cancer Trials Limited
Collaborators
Monash University, University of Sydney, The University of Queensland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Evaluate whether MSP: Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives) Improves health-related quality of life, patient satisfaction, and reduces patient anxiety Reduces costs to patients and health care system Evaluate the safety and acceptability of MSP Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1) 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: Reduction in the number of misclassified melanoma malignancies (i.e. false negatives); Reduction in the number of misclassified melanocytic and keratinocyte lesions combined; Improved quality of life; and Favourable health economic outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
670 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care plus Melanoma Surveillance Photography
Arm Type
Experimental
Arm Description
Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Clinical surveillance standard of care without Melanoma Surveillance Photography.
Intervention Type
Device
Intervention Name(s)
2D or 3D Melanoma Surveillance Photography
Intervention Description
Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.
Primary Outcome Measure Information:
Title
Diagnostic performance of melanoma surveillance
Description
The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness of MSP
Description
Standard health economic cost-effectiveness measures.
Time Frame
24 months
Title
Diagnostic performance for melanoma
Description
Agreement and reliability indices.
Time Frame
24 months
Title
Diagnostic performance for keratinocyte lesions
Description
Agreement and reliability indices.
Time Frame
24 months
Title
Health-Related Quality of life
Description
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.
Time Frame
24 months
Title
Patient anxiety
Description
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).
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
IMAGE Sub-study 1: PRE-TRIAL EXCISION RATES
Description
To estimate the benefit of MSP in high risk patients prior to a melanoma diagnosis, amongst participants who would have been classified as 'high risk' at the time of their primary melanoma, this sub-study will compare: i) Breslow thickness of the primary melanoma at entry into this trial, and ii) Biopsy rates prior to diagnosis
Time Frame
5 year (retrospective)
Title
IMAGE Sub-study 2: TELEDIAGNOSIS VALIDATION
Description
Approximately 100 paired sets of 3D surveillance and digital dermoscopy images (baseline and follow-up) taken from patients in the intervention arm, will be sent to 10 participating study doctors (both GPs and dermatologists; all 100 pairs sent to all 10 doctors) for teledermatology assessment. The study doctors will assess the images with respect to whether they have a melonama present or not. Images will be selected randomly from amongst patients accrued to the main study for this telediagnosis validation study. Approximately 30% of these will include an image of a melanoma confirmed by histopathology (gold standard) during the trial. This substudy will not affect patient care but will assess diagnostic performance (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.
Time Frame
Validity analysis undertaken at a single time point based on data accrued over 24 month study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Mar
Organizational Affiliation
Monash University and Alfred Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Newcastle Skin Check
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Facility Name
Dermatology Clinical Trials Unit, Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Melanoma Institute Australia
City
Wollstonecraft
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Diamantina Institute, University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
FNQH Cairns Skin Cancer Centre
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Skin Repair Skin Cancer Clinic, Townsville
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4812
Country
Australia
Facility Name
Bendigo Cancer Centre Research Unit, Bendigo Health
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Facility Name
Skin Health Institute
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Phillip Island Health Hub, Bass Coast Health
City
Cowes
State/Province
Victoria
ZIP/Postal Code
3922
Country
Australia
Facility Name
Victorian Melanoma Service, Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Wonthaggi Hospital, Bass Coast Health
City
Wonthaggi
State/Province
Victoria
ZIP/Postal Code
3995
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.masc.org.au/image/
Description
Detailed information on the IMAGE trial

Learn more about this trial

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

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