A study looking at a new way to help diagnose melanoma skin cancer (MIAA Validation Study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Melanoma
Skin cancer

Status:

Closed

Phase:

Pilot

This study is looking at a new tool that analyses photographs of moles to see how well it identifies melanoma skin cancer.

More about this trial

The usual way for doctors to diagnose melanoma skin cancer is to take a tissue sample (biopsy Open a glossary item) of the suspicious looking mole. They send it to a specialist doctor (pathologist Open a glossary item) who looks at under a microscope. They confirm if it is or isn’t melanoma. But a lot of moles aren’t cancer (they are benign). This means there are a lot of unnecessary referrals to specialist skin (dermatology) clinics.

It is important to diagnose melanoma early, but researchers think there might be a way to reduce the number of people that undergo a biopsy unnecessarily. So, they have developed a tool (algorithm) to help them do this. It is called the Melanoma Image Analysis Algorithm (MIAA).

In this study, you and/or your doctor will take photographs of the some of your moles. The MIAA algorithm then analyses the images. Your doctor will also take a biopsy of the suspicious mole (or moles) and send it for analysis as usual.

The study team will compare the results of the photos with the results of the biopsy to see if the algorithm can pick up melanoma skin cancer.

The aim of the study is to see how well the algorithm works.

Please note – you won’t benefit if you take part in this study. But it might help people in the future.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this study if all the following apply.
You:

  • are attending a dermatology clinic
  • have at least 1 mole that your doctor is going to take a tissue sample from (biopsy) that is suitable to photograph
  • are at least 18 years old

You cannot take part in the study if you have any other serious medical condition or mental health problem that the study team think could affect you taking part

Trial design

This is a screening study. The study team need about 900 people to join. 

To begin with, the doctor:

  • checks if it is possible to photograph all the moles that need a biopsy
  • finds 2 other moles to photograph that aren’t going to be biopsied

A member of the study team photographs all these moles and an area of healthy skin with a digital camera. They will then ask you to take photos of these same areas with 2 smartphones that have a special lens. An app on the phone will guide you through the process. They will also give you some written instructions. If you can’t photograph the moles yourself, a family member, friend or one of the staff at the hospital can do this for you.

The study nurse will also ask you some questions about your medical history and melanoma risk factors, such as your family history. Depending on the number of moles due for biopsy, taking the photographs takes about 15 to 20 minutes. You then return the phones to the study team.

You will have your mole or moles biopsied as usual. Your doctor will tell you the results of the biopsy when they are available.

The study team will send the photographs of the moles to Skin Analytics for analysis. Neither you nor your doctor will be told the MIAA result. But they will contact your GP if the algorithm identifies melanoma in one of your moles that wasn’t biopsied. But don’t worry about this too much. MIAA hasn’t been fully tested yet so it might identify melanoma incorrectly.

Hospital visits

You should have no extra visits to the dermatology clinic if you take part in this study. The photographs will be taken either as part of your outpatient visit, or prior to your arranged biopsy visit. So one of these will be a little longer than usual.

Side effects

Having a biopsy is part of your usual care. So, you shouldn’t have any extra side effects if you take part in this study.

The side effects of giving a tissue sample include:

  • pain
  • infection
  • bleeding
  • bruising

Your doctor will talk to you about all the possible complications before you have your biopsy.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Ioulios Palamaras

Supported by

Skin Analytics Limited

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15384

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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