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Melanoma (Skin)NCT05015816

MoleGazer Development Feasibility Study

A study testing Total body photography in people with Melanoma (Skin) and Moles Multiple Benign, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Melanoma (skin cancer) frequently develops from existing moles on the skin. Current practice relies on expert dermatologists being able to successfully identify new/changing moles in individuals with multiple moles. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Melanoma (Skin), Moles Multiple Benign
What is being tested?
Total body photography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
1 siteUnited Kingdom
Study dates
13 Sep 2021to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to give informed consent for participation in the study
  • Male or Female, aged 18-80 years old
  • In addition for Group A:
  • Willing to attend for additional study visits and total body photography imaging
  • High-risk melanoma patients including:
  • Dysplastic / atypical naevus syndrome (> 60 moles +/- personal history of melanoma)
Show all 13Show fewer
  • Family history of melanoma
  • Past history of at least two primary melanoma or melanoma-in situ
  • At least 3 first-degree or second-degree relatives with prior melanoma
  • CDKN2A or CDK4 germline mutation
  • Individuals with multiple naevi (>25) who are immunosuppressed from any cause (e.g. organ transplant recipients, chronic lymphocytic leukaemia, etc.)
  • In addition for Group B:
  • ● Has previously had total body photography imaging OR will have total body photography as part of standard care

Who cannot join

  • The participant may not enter the study if ANY of the following apply:
  • Patient unable to consent
  • Patient with active malignancy affecting any organ and receiving any cancer-specific treatment
  • Poor mobility / unable to hold recommended positions for standard TBP imaging
  • Individuals who do not understand English
  • In addition for Group A:
  • ● Unable to attend for three-monthly study visits

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Churchill Hospital

    Headington, Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: MoleGazer: A Feasibility Study for Early Detection of Melanoma

Melanoma (skin cancer) frequently develops from existing moles on the skin. Current practice relies on expert dermatologists being able to successfully identify new/changing moles in individuals with multiple moles. Total body photography (TBP-high-quality images of the entire skin) can track and monitor moles over time to detect melanoma.

However, TBP is currently used as a visual guide when diagnosing melanoma, requiring visual inspection of each mole sequentially. This process is challenging, time-consuming and inefficient. Artificial intelligence (AI) is ideally suited to automate this process. Comparing baseline TBP images to newly acquired photographs, AI techniques can be used to accurately identify and highlight changing moles, and potentially distinguish harmless moles from cancerous changes.

Astrophysicists face a similar problem when they map the night sky to detect new events, such as exploding stars. Using AI, based on two or more images, astrophysicists detect new events and accurately predict how they will appear subsequently. This project, called MoleGazer, is a collaboration with astrophysicists aiming to apply AI methods that are currently used for astronomical sky surveys, to TBP images. The MoleGazer algorithm, developed at Oxford University Hospitals NHS Foundation Trust, will automatically identify the appearance of new moles and characterise changes in existing ones, when new TBP images are taken. To optimise this MoleGazer algorithm TBP images will be taken at multiple time-points, as there are no existing datasets of TBP images that are publicly available. The investigators invite a) high-risk patients attending skin cancer screening clinics to attend sequential three-monthly TBP imaging and clinical assessment and b) any patient who undergoes TBP as standard care to share images so that the investigators can develop the MoleGazer algorithm. The ultimate goal is for the MoleGazer algorithm to 'map moles' over a patient's lifetime to detect changes, with the eventual aim to detect melanoma as early as possible.

Read the detailed description

Background

Melanoma incidence is rapidly increasing with 15,906 new United Kingdom (UK) cases in 2015 resulting in 2,285 deaths. Diagnosing melanoma early is essential as early stage disease has > 95% 5-year relative survival rate compared with 8-25% for advanced melanoma. In the UK, skin cancer costs are predicted to exceed £180 million by 2020 and pose significant morbidity (and mortality) to individuals affected. Up to 60% of melanoma arise from pre-existing naevi (moles). Early melanoma detection relies on individuals recognising changes in naevi and for those individuals with multiple naevi expert assessment of these naevi by trained dermatologists using diagnostic aids such as dermoscopy (x10 magnification). Furthermore there is evidence that sequential surveillance of naevi also increases melanoma detection rates.

Total body photography (TBP) is a diagnostic aid for monitoring of multiple naevi

For patients at high-risk of developing melanoma with multiple naevi (>60), total body photography (TBP) (standardised body-part images taken using high-resolution camera), is used as an aid to track, compare and monitor naevi over time and has been demonstrated to improve melanoma diagnosis. Recommended short-term surveillance monitoring of naevi is 3-months but is largely confined to single lesions. In a resource-constrained National Health Service (NHS), frequent surveillance for multiple naevi by a dermatologist is impractical and inefficient such that early diagnosis of melanoma effectively relies on patient self-surveillance. A potential solution is automated analysis of TBP images using artificial intelligence (AI) to track and monitor naevi over time.

Artificial intelligence applied to TBP could improve efficiency of 'mole-mapping'

Previous AI evaluation of skin lesions has demonstrated equivalent accuracy to trained dermatologists in skin cancer diagnosis, however this relied on single-lesion analysis at static time-points (with biopsy-proven diagnoses). The use of lesions scheduled for excision (i.e., high clinical suspicion of melanoma) severely limits clinical applicability and a Cochrane review concluded that utility of computer-aided detection for melanoma diagnosis in secondary care remains unknown.The more clinically-relevant question is whether automated detection of changes in naevi using sequential TBP images, referred to clinically as 'mole mapping', can indeed improve early diagnosis of melanoma.

To date, TBP systems in the NHS have limited automation, restricted to storing and retrieving images. Although one automated total body scanning system exists, and in the future may incorporate AI-based diagnosis in addition to current image acquisition and lesion matching algorithms, a full clinical validation and any subsequent implementation in the NHS will be costly due to the investment required in the scanning system (current cost US $1 million). Whether the same or better results can be achieved using more conventional image acquisition equipment and sophisticated AI techniques is unknown. The investigators propose a novel application of astronomical AI methods for early melanoma detection using standard TBP-based surveillance of naevi which is currently employed in the NHS and can be used as an adjunct to clinical review of individuals.

Application of astronomical AI techniques to TBP monitoring of multiple naevi

Transient science in astronomy aims to detect and track evolution of new astronomical sources such as exploding stars. Exhibiting both long- and short-term evolution, individual events are detected by comparing new images with archival data and classified based on a feature set, including transient brightness, colour, proper motion and extent. Cutting-edge astronomical surveys monitor the sky every night over multi-year timescales to identify subtle changes. AI techniques (such as random forests and recurrent neural networks; RNN) which use the full time-series history and contextual information are routinely used to identify and classify events probabilistically. With each new observation providing additional information, astronomical transient surveys can routinely detect and characterise new sources, such that the evolution of new sources can be predicted with 99.5% accuracy based on only three time-points.

This challenge faced in astronomy is analogous to 'mole mapping' for individuals at high-risk of developing melanoma; both naevi and astronomical sources can be characterised as distinct sources against a homogeneous background which are tracked across multiple images to detect change. The investigators therefore hypothesise that astronomical AI techniques are ideally suited to address this clinical problem and are developing the MoleGazer project to test this.

Rationale

To develop the MoleGazer algorithm, the investigators require a baseline dataset to apply astronomical AI algorithms to TBP images to detect and track naevi across sequential images. There are currently no publicly available databases of TBP images for the investigators to test this feasibility and therefore in this study the aim is to collect:

  1. a time-series cohort of TBP images taken at fixed sequential time-points over 2 years
  2. a baseline cohort of TBP images with sequential images taken at any time-points By collecting TBP images it will allow the investigators to study the sensitivity of naevi detection and characterisation on skin tone, lighting levels, image registration and background subtraction techniques, enabling the investigators to also automate detection of naevi and track their evolution in any sequential image that the study team has. The development of this database will allow the investigators to demonstrate feasibility of the application of astronomical AI methods to TBP images.
Being tested
Total body photography
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total body photographyDiagnostic test

    3 monthly TBP imaging

Study groups in NCT05015816
Study groupRoleWhat they receive
Group A: Time seriesExperimentalIndividuals at high risk of developing melanoma will be invited to attend for sequential TBP imaging, full body skin examination by a Dermatologist and completion of a case report form (CRF) every three months for two years. At the end of the study participants will also be invited to complete a feasibility questionnaire
Receives: Diagnostic Test: Total body photography
Group B: Baseline cohortNo interventionAll patients who undergo standard care and are selected for total body photography (TBP) imaging will be invited to consent to this group. Any individuals who have had previous TBP imaging will also be eligible to enter Group B of this study. A baseline CRF will be completed and a participant feasibility questionnaire. There will be no additional images taken for the purposes of the study and no additional clinic visits in relation to this part of the study. However, individuals who consent to Group B will also agree to share any future TBP images taken in the department over the next two years so that any sequential images can also be included in the analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional algorithm to map naevi sequentially

    The primary objective of this study is to develop the MoleGazer algorithm

    Measured: 3 years

  2. Number of TBP images in database

    To develop an anonymised database of digital total body photography images

    Measured: 3 years

Secondary outcomes (8)
  1. Proportion of high quality images amenable to evaluation

    Assess the quality of TBP images

    Measured: 3 years

  2. The proportion of participants who complete a dataset of three-monthly imaging (Group A)

    Determine feasibility of patients obtaining regular TBP imaging

    Measured: 2 years

  3. The proportion of TBP images that can be registered and consistently deformed using existing astronomical software adapted for this purpose

    To demonstrate consistently registering all images for use in sequential imaging

    Measured: 1 year

  4. The number of naevi detected by our algorithm from TBP images compared to those determined by an experienced dermatologist

    To detect all naevi in each TBP image

    Measured: 1 year

  5. The distribution of naevi detected by our algorithm from TBP images compared to those determined by an experienced dermatologist

    To detect distribution of all naevi in each TBP image

    Measured: 1 year

  6. The proportion of naevi (as determined by a trained dermatologist) in TBP images discarded when considering an optimal feature set

    To determine a feature set that distinguished between naevi and other skin lesions

    Measured: 3 years

  7. The proportion of sequential TBP images that can be used for naevi detection.

    To develop a database structure to track the evolution of each detected naevus

    Measured: 3 years

  8. The proportion of naevi that are detected and measured in all sequential TBP images

    To study the evolutionary path of naevi in sequential TBP images

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start13 Sep 2021
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015816
Sponsor's protocol ID
14872
Status last verified
Jul 2026
First submitted
19 Dec 2020
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Total body photography in people with Melanoma (Skin) and Moles Multiple Benign, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional algorithm to map naevi sequentially (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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MoleGazer Development Feasibility Study (NCT05015816) | AzTrials