ctDNA for Risk Stratification in Melanoma

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.

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Key information

Conditions

Melanoma (Skin Cancer) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital

Herlev, 2730, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or older
Clinical suspicion of primary cutaneous melanoma
Presenting at the Department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
Able to provide written informed consent

Exclusion criteria

Age less than 18 years
Pregnancy
Inability to provide written informed consent

Treatment and study plan

Primary outcomes

Number of Participants With Detectable Circulating Tumor DNA (ctDNA) in Pre-operative Plasma as Assessed by ddPCR or Targeted NGS

Time frame: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation

A venous blood sample is drawn before surgical excision of the primary melanoma. Plasma is isolated and analyzed for the presence of the same cancer-specific DNA mutation previously identified in the patient's tumor tissue. Two methods are used depending on mutation type: digital droplet PCR (ddPCR, Bio-Rad QX200) for BRAF V600E mutations, or targeted next-generation sequencing (Oncomine Tumor Mutational Load panel, Ion Torrent S5) for other mutations.

A sample is classified as "detected" if at least one confirmed mutant DNA copy is identified by ddPCR, or if the tumor-specific variant is present above the assay detection threshold by NGS. The outcome is reported as the number of participants with detected ctDNA out of the total number of participants analyzed.

Secondary outcomes

Number of Participants With Detectable ctDNA by Tumor Stage as Assessed by ddPCR or Targeted NGS

Time frame: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation.

The number of participants with detectable ctDNA is reported separately for each AJCC 8th edition stage group (IIB, IIC, IIIA, IIIB, IIIC) represented in the study patient cohort. This exploratory outcome evaluates whether more advanced tumor stage is associated with a higher likelihood of ctDNA detection.

Stage is determined from pathological T-classification (based on Breslow thickness and ulceration) and sentinel node status according to AJCC Cancer Staging Manual, 8th edition.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

CAG in Cancer immunotherapy
DCCC ctDNA Research Center
Danish Cancer Research Foundation
Danish Cancer Society

Registry information

Official study title

The Value of Circulating Tumour DNA in Risk Stratification in Melanoma

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2026
First posted: Apr 15, 2026
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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