Clinical trial · Observational
ctDNA for Early Detection of Recurrence in Melanoma
The Value of Circulating Tumour DNA in Early Detection of Recurrence of Melanoma
NCT06246227CI-TRIAL-00109447active 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 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.
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- High Risk Melanoma Patients
- description
- Patients followed-up for Melanoma, Clinical Stages IIB - III and Resected Stage IV
Primary outcomes (2)
- measure
- Sensitivity of ctDNA for detection of metastatic disease
- timeFrame
- From enrollment to end of 5-year follow-up
- description
- 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.
- measure
- Specificity of ctDNA for detection of metastatic disease
- timeFrame
- From enrollment to end of 5-year follow-up
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV Exclusion Criteria: * Pregnancy * Previous history of melanoma
References
Publications (0)
Data not yet available
No reference posted for this study.