Non-invasive skin-tape test to detect melanoma using methylation biomarkers
Official title: Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test
Run by Mitra Bio · NCT07883954 · Data updated 2026-11-12
A non-invasive skin-tape test is being tried to see if it can detect melanoma in people who are about to have a biopsy for a suspicious pigmented lesion.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Mitra Bio Industry-sponsored |
| Locations | 5 sites (Ghent and 4 other locations) |
| Status | Recruiting |
| Started | June 10, 2026 |
| Main results expected | October 10, 2027 |
| Study ends | November 15, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07883954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older scheduled for a biopsy or excision of a suspicious pigmented lesion at participating centers.
✕Probably not a fit
Patients whose lesions are clearly benign or malignant may not experience direct benefit from the test, though data may still inform future care.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to develop and prospectively validate a methylation biomarker-based test applied to skin samples collected with non-invasive tape. The approach uses a panel of melanoma-specific methylation markers and an analytical algorithm to differentiate melanoma from non-melanoma lesions. Participants are adults undergoing standard-of-care biopsy for a suspicious pigmented lesion and will provide a tape sample before biopsy. The study collects data at a single visit or around the time of biopsy to assess test performance. No interventional treatment is studied; the focus is on diagnostic accuracy and validation across multiple centers.
Why it matters
Potential benefit: If successful, the test could reduce unnecessary biopsies by improving non-invasive melanoma detection.
How similar studies have gone: Previous research in molecular diagnostics for melanoma has shown promise with non-invasive sampling, but validation of this specific methylation biomarker panel in a prospective multi-center setting is still evolving.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Individuals with significant skin disease that is outside the scope of the diseases which will be investigated * 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) * Individuals with learning difficulties, severely ill patients, and other vulnerable groups (e.g., mental illness, dementia) * Individuals outside the defined age group * Use of any investigational or non-registered product (drug, vaccine or invasive medical device) within the previous 8 weeks. * Individuals with an allergy that may interfere with the procedure.
Where it's running
-
Ghent University Hospital
Ghent, Belgium Recruiting -
University Hospital Tuebingen
Tübingen, Germany Recruiting -
Royal Free Hospital
London, United Kingdom Recruiting -
Whittington Hospital
London, United Kingdom Recruiting -
Idibaps
Barcelona, Spain Not yet recruiting
Study contacts
- Principal investigator: Josep Malvehy, MD — Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Study coordinator: Stephanie Juniat
- Email: stephanie@mitrabio.tech
- Phone: 734-358-9550
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.