Checking a skin tape test for melanoma alongside the usual biopsy
Studies a skin tape test for melanoma before planned biopsies.
Plain-language title generated from the registry record
Registry title: Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test
Key facts
- Where
- Ghent, BelgiumSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are about to have a standard biopsy or excision of a dark (pigmented) skin spot that may be melanoma. A skin tape sample is taken from the spot before the biopsy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- A pigmented skin lesion suspected of being melanoma, scheduled for a standard biopsy or excision
- Earlier treatment
- No investigational or non-registered product (drug, vaccine or invasive medical device) in the previous 8 weeks
Main reasons for not taking part
- Significant skin disease outside the diseases studied
- Other skin problems at the lesion site
- Lesion on the palms, soles of the feet, or a very hairy area such as the scalp or beard area
- Learning difficulties, severe illness, or other vulnerable groups such as mental illness or dementia
- Allergy that may interfere with the procedure
Read by machine on 13 November 2026.
Where in Belgium
- Ghent university hospitalGhent, BelgiumContact: Isabel De VuysdereTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Mitra Bio
- Trial code
- NCT07883954
- Record updated
- 21 October 2026
- Original description
Background and Study Aims:Read full original descriptionShow less
Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test
Background and Study Aims:
Melanoma is the most dangerous form of skin cancer, and early detection is crucial for improving patient outcomes. Over 90% of suspected skin cancer lesions are not melanoma, leading to a significant proportion of patients undergoing invasive skin biopsies for non-relevant lesions (1). Mitra Bio has developed a novel, non-invasive skin-tape test that captures skin cells from pigmented lesions that are suspected of being melanoma and detects the presence of melanoma-specific methylation biomarkers.
The goal of this study is to further develop and to prospectively clinically validate Mitra Bio's methylation biomarkers and algorithm, applied to skin samples collected non-invasively using skin-tapes, for the detection of melanoma.
Who can participate?
We will invite people from participating hospitals who:
-are scheduled for a standard of care biopsy of a suspicious lesion What does the study involve? All participants will have a one-time visit prior to their standard of care biopsy appointment. This visit will include clinical data collection, tape sample collection, and a participant survey.
Discovery Cohort: Involves using a tape sample collection method on the suspicious lesion, healthy contralateral skin, and the forehead.
Validation Cohort: Involves using tape sample collection method on only the suspicious lesion.
The participant's active role in the study concludes after this one visit. The research team will collect and review pathology data from the standard of care biopsy.
What are the risks and benefits of participating? This study could help improve non-invasive diagnostics for melanoma, significantly reducing the number of unnecessary biopsies. By taking part, you make that possible.
The tape sample collection is not painful and most people have no reaction. Mild and temporary skin redness and discomfort at the sampling site are the most common complaints.
Inclusion: At least 18 years of age; Undergoing a standard of care biopsy or excision procedure for a pigmented lesion that is suspected of being a melanoma; Willing and able to sign informed consent; Willing to undergo a non-invasive skin tape sample collection procedure prior to standard of care biopsy/excision (up to 1 week prior to or on the day of the biopsy/excision procedure); Able to complete both the tape collection and biopsy/excision procedures.
Exclusion: Use of any investigational or non-registered product (drug, vaccine or invasive medical device) within the previous 8 weeks; Individuals with significant skin disease that is outside the scope of the diseases which will be investigated; Individuals with learning difficulties, severely ill patients, and other vulnerable groups (e.g., mental illness, dementia); Individuals with an allergy that may interfere with the procedure; Individuals outside the defined age group; Individuals who have other skin complications at the lesion site Suspicious pigmented lesion is located on the palms, soles of feet, or a highly hair-dense anatomical site (e.g., scalp, beard area).