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

Condition(s) studied

Study 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

Primary outcome measure(s)

• Primary Discovery Outcome — 6 Months
  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).
• Primary Validation Outcome — 6 Months
  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.

Trial sites (5)

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