Clinical trial NCT01878396: Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors
Official title: Predictive Value of Circulating Melanoma Cells (CMCs) in Metastatic Melanoma (MM) Patients Treated With Selective Inhibitors of BRAF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Melanoma
Keywords: Circulating Melanoma cells in metastatic melanoma
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
Collaborators: name: Janssen Diagnostics, LLC
First posted: 2013-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

Eligibility 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.

Primary outcomes:
measure: Change of CMC count during treatment and comparison with CT and PET
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Vanna Chiarion-Sileni, MD
state: PD
Study officials:
affiliation: Padua University
name: Paola Zanovello, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mocellin S, Del Fiore P, Guarnieri L, Scalerta R, Foletto M, Chiarion V, Pilati P, Nitti D, Lise M, Rossi CR. Molecular detection of circulating tumor cells is an independent prognostic factor in patients with high-risk cutaneous melanoma. Int J Cancer. 2004 Sep 20;111(5):741-5. doi: 10.1002/ijc.20347.