Clinical trial · Observational
ctDNA for Risk Stratification in Melanoma
The Value of Circulating Tumour DNA in Risk Stratification in Melanoma
NCT07531121CI-TRIAL-00108240active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Primary Melanoma Patients
- description
- 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.
Primary outcomes (1)
- measure
- Number of Participants With Detectable Circulating Tumor DNA (ctDNA) in Pre-operative Plasma as Assessed by ddPCR or Targeted NGS
- timeFrame
- At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation
- description
- 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 (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.