Metastatic Melanoma
Conditions
Keywords
Circulating Melanoma cells in metastatic melanoma
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 selective inhibitors of mutated B-RAF.
Interventions
DRUGAnti-B-RAF
Sponsors
Janssen Diagnostics, LLC
Istituto Oncologico Veneto IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of CMC count during treatment and comparison with CT and PET | 24 months |
Countries
Italy
Contacts
Primary ContactVanna Chiarion-Sileni, MD
Backup ContactRita Zamarchi, MD
Outcome results
None listed