Status:
UNKNOWN
Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors
Lead Sponsor:
Istituto Oncologico Veneto IRCCS
Collaborating Sponsors:
Janssen Diagnostics, LLC
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
This is an observational prospective pilot study aimed to investigate the association between changes of total and apoptotic CMC count and disease progression in MM patients undergoing treatment with ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01878396
Start Date
December 1 2011
End Date
December 1 2017
Last Update
October 3 2016
Active Locations (1)
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1
Vanna Chiarion-Sileni, MD
Padua, PD, Italy, 35128