Evidence map›Paper›PMID 36991460›Full record

ArticleTrials2023

Study protocol for a randomised controlled trial to evaluate the use of melanoma surveillance photography to the Improve early detection of MelanomA in ultra-hiGh and high-risk patiEnts (the IMAGE trial).

Mabel K Yan, Anne E Cust, H Peter Soyer, Monika Janda, Katja Loewe, Gabrielle Byars, Paul Fishburn, Paul White, Rashidul Alam Mahumud, Robyn P M Saw and 7 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04385732 (Melanoma Surveillance Photography), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04385732 naactive not recruitingnot on this map

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

TypeinterventionalSponsorMelanoma and Skin Cancer Trials LimitedRan2021 to 2025Enrolled670ConditionsMelanoma, Skin Cancer, Anxiety and FearArms2D or 3D Melanoma Surveillance Photography
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Mabel K YanSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC, 3004, Australia. mabelkyan@gmail.com.ORCID http://orcid.org/0000-0002-4700-3781
Anne E CustThe Daffodil Centre, The University of Sydney, a Joint Venture With Cancer Council NSW, Sydney, Australia.
H Peter SoyerDermatology Research Centre, The University of Queensland Diamantina Institute, The University of Queensland, Brisbane, QLD, Australia.
Monika JandaCentre for Health Services Research, The University of Queensland, Brisbane, QLD, Australia.
Katja LoeweMelanoma and Skin Cancer Research Centre, Monash University, Melbourne, VIC, Australia.
Gabrielle ByarsMelanoma and Skin Cancer Research Centre, Monash University, Melbourne, VIC, Australia.
Paul FishburnNorwest Skin Cancer Centre, Bella Vista, New South Wales, Australia.
Paul WhiteMelanoma and Skin Cancer Research Centre, Monash University, Melbourne, VIC, Australia.
Rashidul Alam MahumudNHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.
Robyn P M SawMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Alan HerschtalSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC, 3004, Australia.
Pablo Fernandez-PenasFaculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Pascale GuiteraMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Rachael L MortonMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
John KellyVictorian Melanoma Service, Alfred Hospital, Melbourne, VIC, Australia.
Rory WolfeSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC, 3004, Australia.
Victoria J MarSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC, 3004, Australia.

Funding

Medical Research Future Fund - Targeted Health System and Community Organisation Research RGMS ID: 1175082
6 · The paper itself

Abstract

introductionMelanoma surveillance photography (MSP) is a comprehensive surveillance method that comprises two- or three-dimensional total body photography with tagged digital dermoscopy, performed at prescribed intervals. It has the potential to reduce unnecessary biopsies and enhance early detection of melanoma, but it is not yet standard care for all high-risk patients in Australia. This protocol describes a randomised controlled trial (RCT) designed to evaluate the clinical impact and cost-effectiveness of using MSP for the surveillance of individuals at ultra-high or high risk of melanoma from a health system perspective. METHODS AND

designThis is a registry-based, unblinded, multi-site, parallel-arm RCT that will be conducted over 3 years. We aim to recruit 580 participants from three Australian states: Victoria, New South Wales and Queensland, via state cancer registries or direct referral from clinicians. Eligible participants within 24 months of a primary cutaneous melanoma diagnosis will be randomised 1:1 to receive either MSP in addition to their routine clinical surveillance (intervention group) or routine clinical surveillance without MSP (control group). Most participants will continue surveillance with their usual care provider, and the frequency of follow-up visits in both groups will depend on the stage of their primary melanoma and risk factors. The primary outcome measure of the study is the number of unnecessary biopsies (i.e. false positives, being cases where a lesion is biopsied due to suspected melanoma on clinical examination, either with or without MSP, but the resulting histopathology finding is negative for melanoma). Secondary outcomes include the evaluation of health economic outcomes, quality of life and patient acceptability. Two sub-studies will explore the benefit of MSP in high-risk patients prior to a melanoma diagnosis and the diagnostic performance of MSP in the teledermatology setting compared to the en face clinical setting. DISCUSSION: This trial will determine the clinical efficacy, cost-effectiveness and affordability of MSP to facilitate policy decision-making at the national and local levels, across primary and specialist care.

trial registrationClinicalTrials.gov NCT04385732 . Registered on May 13, 2020.

Indexed as

MelanomaSkin NeoplasmsCost-Benefit AnalysisEarly Detection of CancerHumansPhotographyRandomized Controlled Trials as TopicVictoriaCost–benefit analysisEarly detectionMelanomaRandomised controlled trialSecondary preventionSurveillanceTotal body photography

Identifiers

PMID36991460
PMCPMC10061902

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.