Observational studyCancer research communications2026
Melanoma Recurrence Prediction Using a Tissue-Free Epigenomic Molecular Residual Disease Assay: A Multicenter Prospective Observational Study (COSMOS-MEL01).
Observational study in Cancer research communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Despite recent adoption of perioperative therapy for high-risk melanoma, its overall survival (OS) benefit remains unclear, highlighting the need for biomarkers to identify patients likely to benefit from treatment. Detection of circulating tumor DNA (ctDNA) after definitive treatment predicts recurrence, and emerging molecular residual disease (MRD) assays may influence management. We validated a tissue-free MRD assay in 48 patients with clinical stage II to III melanoma treated with surgery (52% nonacral cutaneous, 31% acral, and 17% mucosal). The assay detects MRD through bioinformatic analysis of methylation signals across >20,000 epigenomic regions. Plasma samples (n = 281; 280 successfully reported) were prospectively collected before surgery, at day 28, and every 3 to 6 months thereafter. Associations among MRD detection, recurrence, and OS were analyzed. At a median follow-up of 34.6 months with 27 recurrence events, postoperative surveillance sensitivity for distant recurrence was 81% with 100% posttreatment specificity. The median lead time between MRD detection and radiographic recurrence was 70.5 days. Surveillance MRD detection was associated with increased recurrence risk [hazard ratio (HR), 26.55; 95% confidence interval (CI), 2.86-246.58; P = 0.004]. Similarly, MRD detection 28 days postoperatively independently predicted recurrence (HR, 11.70; 95% CI, 3.09-43.76; P < 0.001) and death (HR, 31.14; 95% CI, 5.37-221.1; P < 0.001). Tissue-free epigenomic MRD detection was sensitive, specific, and significantly associated with recurrence and melanoma-related death. These findings support the use of this assay in melanoma as a rapid, noninvasive approach for earlier identification of patients at high risk for recurrence, enabling refined treatment and surveillance strategies. SIGNIFICANCE: Prognostic tools for high-risk melanoma rely on baseline factors with limited dynamic risk assessment. A tissue-free MRD assay demonstrated high sensitivity and specificity for distant recurrence detection, identifying molecular relapse before radiographic recurrence. Postoperative MRD detection was strongly associated with recurrence and melanoma-related death, enabling refined treatment and surveillance strategies.
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