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Predictive Value of Circulating Melanoma Cells (CMCs) in Metastatic Melanoma (MM) Patients Treated With Selective Inhibitors of BRAF


N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

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Trial Information

Predictive Value of Circulating Melanoma Cells (CMCs) in Metastatic Melanoma (MM) Patients Treated With Selective Inhibitors of BRAF


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change of CMC count during treatment and comparison with CT and PET

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Paola Zanovello, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Padua University

Authority:

Italy: Ethics Committee

Study ID:

IOV2011/35

NCT ID:

NCT01878396

Start Date:

December 2011

Completion Date:

July 2014

Related Keywords:

  • Metastatic Melanoma
  • Circulating Melanoma cells in metastatic melanoma
  • Melanoma

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