metastatic melanoma, circulating melanoma cells, leukapheresis
Conditions
Interventions
From all patients, blood will be drawn to screen for eligibility, including a CellSave tube for CMC count and tubes for liver, renal and bone marrow function. If eligible, patients will undergo a leuk
Sponsors
Erasmus Medical Center, Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with metastatic melanoma • Known BRAF mutation detected on primary tumor tissue • Starting new line of systemic treatment for metastatic disease, irrespective of treatment modality (i.e. BRAF-targeted therapy or immunotherapy) • Age ≥18 years
Exclusion criteria
Exclusion criteria: • Patients with a known hypersensitivity to the used LA anticoagulant • Inadequate liver function: - Total bilirubin > 2.5 x ULN • Inadequate renal function. - Creatinine > 1.5 x ULN or; - Creatinine clearance (calculated by Cockcroft) 1.5 x ULN or PT-INR > 1.5; d. APTT > 1.5 x ULN. • Chronic viral infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with cells positive for any melanoma specific marker identified by flow cytometric analysis of LA product. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The comparison of putative CMC counts as identified by flow cytometry and CellSearch in blood and LA product - BRAF mutation status in different CMC subsets as identified by flow cytometry. | — |
Contacts
Public ContactS. Sleijfer
Department of Oncology, Erasmus MC Cancer institute, room He 116
Outcome results
None listed