NCT07883954 Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test
| NCT ID | NCT07883954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mitra Bio |
| Condition | Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2026-06-10 |
| Primary Completion | 2027-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2026-06-10 with a primary completion date of 2027-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Josep Malvehy, MD
PRINCIPAL INVESTIGATOR
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Frequently Asked Questions
Who can join the NCT07883954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07883954 currently recruiting?
Yes, NCT07883954 is actively recruiting participants. Contact the research team at stephanie@mitrabio.tech for enrollment information.
Where is the NCT07883954 trial being conducted?
This trial is being conducted at Ghent, Belgium, Tübingen, Germany, Barcelona, Spain, London, United Kingdom and 1 additional location.
Who is sponsoring the NCT07883954 clinical trial?
NCT07883954 is sponsored by Mitra Bio. The principal investigator is Josep Malvehy, MD at Institut d'Investigacions Biomèdiques August Pi i Sunyer. The trial plans to enroll 2,000 participants.
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