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

Melanoma Clinical Trial

— IMAGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04385732
• Other study ID #: 02.19
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: February 2025

Study information

• Verified date: April 2023
• Source: Melanoma and Skin Cancer Trials Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 670
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety and Fear
• Melanoma
• Skin Cancer

Intervention

Device:
• 2D or 3D Melanoma Surveillance Photography
Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.

Locations

Country	Name	City	State
Australia	Bendigo Cancer Centre Research Unit, Bendigo Health	Bendigo	Victoria
Australia	Diamantina Institute, University of Queensland	Brisbane	Queensland
Australia	FNQH Cairns Skin Cancer Centre	Cairns	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Skin Health Institute	Carlton	Victoria
Australia	Phillip Island Health Hub, Bass Coast Health	Cowes	Victoria
Australia	Victorian Melanoma Service, Alfred Health	Melbourne	Victoria
Australia	Newcastle Skin Check	Newcastle	New South Wales
Australia	Dermatology Clinical Trials Unit, Westmead Hospital	Sydney	New South Wales
Australia	Skin Repair Skin Cancer Clinic, Townsville	Townsville	Queensland
Australia	Melanoma Institute Australia	Wollstonecraft	New South Wales
Australia	Wonthaggi Hospital, Bass Coast Health	Wonthaggi	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Melanoma and Skin Cancer Trials Limited	Monash University, The University of Queensland, University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IMAGE Sub-study 1: PRE-TRIAL EXCISION RATES	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	5 year (retrospective)
Other	IMAGE Sub-study 2: TELEDIAGNOSIS VALIDATION	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.	Validity analysis undertaken at a single time point based on data accrued over 24 month study period.
Primary	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.	24 months
Secondary	Cost-effectiveness of MSP	Standard health economic cost-effectiveness measures.	24 months
Secondary	Diagnostic performance for melanoma	Agreement and reliability indices.	24 months
Secondary	Diagnostic performance for keratinocyte lesions	Agreement and reliability indices.	24 months
Secondary	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.	24 months
Secondary	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).	24 months

External Links

•   Detailed information on the IMAGE trial