Flow cytometric analysis of circulating melanoma cells after enrichment by leukapheresis

Flow cytometric analysis of circulating melanoma cells after enrichment by leukapheresis - FAME

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49343

Enrollment

Registered

2018-11-16

Start date

2019-04-19

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic melanoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Patients with metastatic melanoma * Starting new line of systemic treatment for metastatic disease, irrespective of treatment modality (i.e. BRAF-targeted therapy or immunotherapy) or with progression under current treatment * Age *18 years

Exclusion criteria

Exclusion criteria: * Known hypersensitivity to the anticoagulant used for apheresis * Inadequate cardiac function or severe cardiovascular comorbidity a. Heart failure NYHA class III/IV * Hemoglobin level 1.5 x ULN or PT-INR > 1.5 x ULN d. APTT > 1.5 x ULN Patients who take anticoagulant therapy which affects PT or APTT if: e. PT or APTT > 1.5 x the upper limit of the desired therapeutic window f. Total bilirubin > 2.5 x ULN

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study will be to determine the percentage of patients with cells positive for any melanoma specific marker identified by flow cytometric analysis of LA product.	—

Secondary

Measure	Time frame
Secondary endpoints are the comparison of putative CMC counts as identified by flow cytometry and CellSearch in blood and LA product and mutation status of a mutation, present on primary- or metastatic tumor tissue, in different CMC subsets as identified by flow cytometry.	—

Countries

Netherlands

Outcome results