ctDNA for Risk Stratification in Melanoma

NCT07531121 | Active Not Recruiting

• 1 other identifier: H-18008586-S2
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma (Skin Cancer)

Keywords

ctdna; melanoma; stratification; ddpcr; ngs; biomarker

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

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

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

Study Arms (1)

Primary Melanoma Patients

Patients presenting with suspected primary melanoma prior to surgical excision. Patients that are shown to have invasive melanoma of stage T3a or higher, OR sentinel node metastasis N1a or higher OR distant metastasis M1 or higher, and a targetable tumor mutation in tissue sample are selected for ctDNA analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with suspicion of primary melanoma at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, in the inclusion period.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Danish Cancer Society: collaborator
• Danish Cancer Research Foundation: collaborator
• DCCC ctDNA Research Center: collaborator
• CAG in Cancer immunotherapy: collaborator

Study Sites (1)

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

Herlev, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples analyzed for mutations using next-generation sequencing (Oncomine Tumor Mutational Load panel). Plasma isolated from pre-operative venous blood samples, stored for ctDNA analysis by ddPCR or targeted NGS.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Lisbet R Hölmich, MD, DMSc, Professor

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Medical Doctor, PhD Student

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 15, 2026
• Study Start: September 10, 2021
• Primary Completion: May 20, 2025
• Study Completion: May 3, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)