NCT07531121

ctDNA for Risk Stratification in Melanoma

The Value of Circulating Tumour DNA in Risk Stratification in Melanoma

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 296 (actual)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study examines circulating tumor DNA (ctDNA) as a biomarker in patients with primary melanoma, prior to surgical excision. The hypothesis is that ctDNA may be detectable in pre-operative blood samples from patients with high-risk primary melanoma, potentially providing a baseline measurement for future disease monitoring.

Detailed description

This prospective, single-institution study recruits patients presenting with suspected primary melanoma at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University. Patients with invasive melanoma of stage T3a or higher, or with sentinel node metastasis (N1a or higher), and no distant metastasis (M0) will be selected for final analysis. Pre-operative blood samples are collected prior to surgical excision. Plasma is harvested and stored. Tumor tissue from excised melanomas is analyzed using next-generation sequencing (NGS, Oncomine Tumor Mutational Load panel) to determine the mutational profile. For patients with targetable mutations, corresponding plasma samples are analyzed for ctDNA using either digital droplet PCR (ddPCR) or plasma NGS depending on the local availability of validated mutation-specific assays. Enrollment will take place from September 2021 to December 2022, with laboratory analyses expected to be completed in 2025 and final analysis completed by May 2026. This study shares the ethical approval (H-18008586) and biobank infrastructure with a parallel study investigating ctDNA for detection of melanoma recurrence (NCT06246227).

Conditions

• Melanoma (Skin Cancer)

Timeline

• Start date: 2021-09-10
• Primary completion: 2025-05-20
• Completion: 2026-05-03
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Denmark