Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated BRAF.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Oncologico Veneto IRCCS
• Collaborator: Janssen Diagnostics, LLC

Criteria

Inclusion Criteria:

• Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors will be included. To determine the prevalence of CMC-positive patients in IV stage Melanoma, patients without mutated B-RAF undergoing chemotherapy and/or vaccines will be also enrolled at baseline, as part of study protocols approved and activated in the participating centers.

• Informed written consent.

Exclusion Criteria:

• Inadequate compliance to multiple blood draws (baseline, 15 days, 1th month, 4th month, and/or at progression) as scheduled in this adjunctive biologic study for patients carrying B-FAF mutation; inadequate compliance to adjunctive blood draws, as scheduled at baseline for BRAF wild-type

• Previously exposure to immunological treatment.