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Clinical Trials in Denmark / NCT06246227
Active, not recruiting Observational

ctDNA for Early Detection of Recurrence in Melanoma

NCT06246227 · tracked via the Priya Life Science Denmark tracker
Sponsor
Herlev and Gentofte Hospital
Phase
Observational
Started
2019-07-01
Last updated
2026-04-24

Condition(s) studied

Melanoma

Study summary

This study examines circulating tumor DNA (ctDNA) as a biomarker for early detection of recurrence in high-risk patients, following treatment of primary melanoma. The hypothesis is that ctDNA can provide accurate detection of recurrence or metastasis, at the time of or earlier than current methods, leading to improved management and hopefully prognosis, based on earlier detection.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV Exclusion Criteria: * Pregnancy * Previous history of melanoma

Primary outcome measure(s)

  • Sensitivity of ctDNA for detection of metastatic disease — From enrollment to end of 5-year follow-up
    By analyzing blood samples of patients diagnosed with recurrence, we will establish the ability of ctDNA to detect known recurrence, and therefore be able to establish the sensitivity of the method.
  • Specificity of ctDNA for detection of metastatic disease — From enrollment to end of 5-year follow-up
    By assuming no ctDNA in healthy individuals and analyzing WBC from buffy-coat to correct for wild-type mutated DNA due to CHIP, we will be able to establish the specificity of the method.

Trial sites (1)

FacilityCityRegionStatus
Detp. of Pastic and Reconstructive Surgery, Herlev Hospital Herlev Denmark

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Other trials for the same condition

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) Recruiting
Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors Active, not recruiting
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors Active, not recruiting
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06246227 on ClinicalTrials.gov ↗ ← All trials in Denmark