RecruitingOBSERVATIONAL

Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test

Melanoma is a serious type of skin cancer where early detection is vital. At present, doctors often need to carry out a biopsy—cutting away a small piece of skin—to find out if a mole is dangerous. However, over nine out of ten tested moles turn out to be harmless. This clinical study is evaluating a new, painless method developed by Mitra Bio. Researchers gently apply medical tape to a suspicious mole to lift surface cells. They then examine these cells for biological clues linked to cancer. If you are already booked in for a hospital biopsy on a suspicious mole, you may be able to take part. Joining involves just one visit before your planned procedure to collect the tape sample and answer a brief questionnaire. Your normal care will not be delayed, and you could help future patients avoid unneeded skin surgery.

At a glance

Status

Recruiting

Sponsor

Mitra Bio

Enrolment target

2,000

Start

10 Jun 2026

Estimated completion

15 Nov 2027

Melanoma

What is this study about?

Melanoma is a type of skin cancer that often begins in moles. When caught early, it is usually straightforward to treat, which is why doctors take unusual skin changes very seriously. To check if a mole is cancerous, doctors routinely perform a biopsy by numbing the skin and removing tissue with a scalpel. While this standard procedure is safe, it involves needles, cuts, and stitches. Remarkably, more than 90% of these tests show that the mole was completely safe, meaning many people undergo surgery they did not strictly need.

To make skin checks easier and kinder, scientists have designed a non-invasive test that works using special adhesive tape. By pressing the tape against a mole and peeling it away, doctors can collect loose surface skin cells without cutting into the flesh. In a laboratory, researchers can study the genetic material in these cells to check for specific chemical signals that indicate whether cancer is present.

This study is testing the tape method in NHS hospitals to confirm how reliable it is in day-to-day healthcare. By comparing the tape test results with the results of regular biopsies, the research team wants to prove that the sticky-tape method works accurately. If it is successful, the test could help doctors quickly rule out melanoma in the future, sparing thousands of people each year from anxiety, scars, and unnecessary procedures.

Key takeaways

Tests a needle-free sticky-tape method designed to detect melanoma markers.
Open to adults who already have a hospital biopsy scheduled for a suspicious mole.
Requires only one short visit before or on the day of your planned procedure.
Your routine NHS care and biopsy will carry on exactly as planned.
The test is gentle, carrying very little risk beyond mild, temporary skin redness.

Who may be eligible?

You may be able to join this study if you are 18 or older and already have an appointment booked for a routine biopsy or minor operation to check a suspicious mole. You will need to be willing to have the tape test done either on the day of your planned procedure or up to one week beforehand.

The trial is not suitable for people whose suspicious mole is located on the palms of the hands, the soles of the feet, or very hairy areas such as the scalp or beard. You will also not be able to participate if you have widespread skin conditions, known allergies to medical tapes or plasters, or if you have taken part in another clinical trial within the past eight weeks.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am at least 18 years old.
I am already scheduled to have a hospital biopsy or removal of a suspicious mole.
My suspicious mole is not on my palms, the soles of my feet, or a hairy area like my scalp.
I do not have an allergy to medical tapes, glues, or plasters.
I have not taken part in another clinical trial within the last 8 weeks.

Answer every question to see your result.

What does participation involve?

Taking part involves just a single visit to the hospital clinic, arranged to fit around your existing appointment. It will take place either on the same day as your planned biopsy or up to a week before, meaning your regular medical treatment will not be delayed. During the visit, a researcher will press small pieces of tape onto your suspicious mole to collect surface cells. Depending on which study group you are in, they may also take samples from an area of healthy skin and your forehead to compare results. You will also be asked to fill out a short feedback survey. No trial medications are given. Once your tape sample is collected, your active part in the study is finished, and your routine biopsy will go ahead as usual. The researchers will later check your hospital biopsy results to see how well their tape test matched.

Potential risks and benefits

Taking part will not change your own diagnosis or treatment, but your contribution could help doctors develop simpler, needle-free ways to check for skin cancer in the future. The tape collection is very gentle and generally painless. The main potential side effect is mild, temporary redness or slight tenderness where the tape was placed, much like removing an ordinary sticking plaster. You are free to change your mind and leave the study at any point, and doing so will not affect your routine NHS care in any way.

Locations (5)

Ghent University Hospital
Verified postcode
Ghent, Belgium· Recruiting
University Hospital Tuebingen
Verified postcode
Tübingen, Germany· Recruiting
IDIBAPS
Verified postcode
Barcelona, Spain· Not yet recruiting
Royal Free Hospital
Verified postcode
London, United Kingdom· Recruiting
Whittington Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

Does the skin-tape test hurt?

No. The test is generally painless and feels very similar to having a plaster pressed onto your skin and then gently removed.

Will this replace my planned biopsy?

No. You will still have your standard hospital biopsy as planned. The tape test is an extra research step to check how well the new method works.

Will taking part delay my cancer checks?

No. The tape sample is taken either just before your scheduled biopsy or up to a week in advance, so your normal treatment stays on schedule.

Will I receive the results from the tape test?

No. Because this test is still being developed and checked for accuracy, your doctors will rely entirely on your standard biopsy results to decide your care.

How much time will taking part take?

It involves just one brief appointment. Once the researcher has taken the tape samples and you have answered a short survey, your involvement is complete.

How to find out more

Stephanie Juniat

stephanie@mitrabio.tech 734-358-9550 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.