DRKS00009507
Recruiting
Not Applicable
Pilot study to evaluate the feasibility and prognostic significance of detection of mutated, free circulating tumor DNA in plasma of patients with melanoma - ctDNA Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- C43.0
- Sponsor
- niversitätsklinikum Freiburg
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed melanoma
- •2\. Locally advanced (stage III) or metastatic (stage IV) disease
- •3\. Primary diagnosis or relapse or progression
- •4\. Planned resection of one or more disease manifestations or planned systemic treatment
- •5\. Known activating mutation of BRAF or NRAS or mutation status unknown and tissue sample can be provided for mutation analysis at screening
- •6\. At least one melanoma lesion that can be measured by CT, PET\-CT, or MRI (stage IV only)
- •7\. Routinely planned follow\-up visits at intervals of no longer than three months including S100, LDH and local standard of care diagnostic imaging
Exclusion Criteria
- •1\. Uveal melanoma
- •2\. Surgery of primary or progressive lesions already completed and currently no evidence of progressive lesions
- •3\. Wild\-type sequence of tissue specimen for BRAF and NRAS genes
- •4\. More than one line of previous systemic treatment (stage IV only)
- •5\. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin
Outcomes
Primary Outcomes
Not specified
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