A method to predict clinical outcomes for melanoma patients using blood circulating melanoma cells

摘要

A method for predicting overall survival for patients with metastatic melanoma in a 7.5 mL blood sample that had been obtained from a patient with metastatic melanoma, said mixture comprising a mixed cell population suspected of containing circulating melanoma cells; wherein the method comprises: (a) enriching a fraction of said specimen by immunomagnetic enrichment using an externally applied magnetic field to separate paramagnetic particles coupled to CD146 antibodies, until substantial exclusion from other populations, said fraction containing said circulating melanoma cells; (b) confirm structural integrity of said circulating melanoma cells so that they are intact, where said structural integrity is determined by a nucleic acid dye and a monoclonal antibody specific for melanoma associated antigen with high molecular weight, and which also contains CD45 and CD34 to exclude co-enriched leukocytes and circulating endothelial cells; (c) analyze said circulating melanoma cells; where said analysis correlates with the progression of the disease; (d) evaluate the number of circulating melanoma cells in said blood sample; where if the number is greater than or equal to 2 it is predicted that the overall survival of the patient will not be more than two months, and if the number of circulating melanoma cells is less than 2, it is predicted that the overall survival of the patient will be 12 months