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

Recruitingn/aAges 18 Years - anyAllMitra Bio
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In plain words

What the trial is, and whether it could suit you

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 susp

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

5 sites
Ghent University Hospital
Ghent, Belgium
University Hospital Tuebingen
Tübingen, Germany
IDIBAPS
Barcelona, Spain
Royal Free Hospital
London, United Kingdom
Whittington Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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