An observational study in Melanoma, sponsored by Mitra Bio. Recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Mitra Bio · Observational
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 182 across 448 observational studies indexed under Melanoma.
Browse Melanoma studies →This is the only study on the registry with Mitra Bio as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adults undergoing a standard of care biopsy of a suspicious skin lesion
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To identify and optimise a panel of methylation biomarkers from non-invasively collected skin-tape samples that can distinguish melanoma from non-melanoma skin lesions.
To prospectively evaluate the diagnostic performance (sensitivity and specificity) of the finalised methylation biomarker panel and associated algorithm for the detection of melanoma, as applied to skin-tape samples from patients routinely referred for biopsy or excision of a suspected melanoma, compared against biopsy and histology as the diagnostic reference standard.
Primary Discovery Outcome
Identification and optimisation of methylation biomarkers capable of distinguishing melanoma from non-melanoma lesions. Differential methylation effect sizes and statistical significance (CpG sites and regions).
Time frame: 6 Months
Primary Validation Outcome
Performance of biomarkers in differentiating melanoma from non-melanoma samples in the study population: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), each with 95% CIs.
Time frame: 6 Months
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for Oct 2027, 16 months after the start.
Of 52 industry-sponsored observational studies under Melanoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 69. This study's planned 16 months is below that.
Counting every sponsor, half of 206 studies reached it within 82 months; a quarter within 37 and three quarters within 223.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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