Prospective Collection of Biological Data of Prognostic Relevance in Patients
Clinical data including information on disease localization and laboratory parameters will
be collected at study entry, during follow up and at disease progression (or after 36 months
after registration) Biological markers will be evaluated at centralized laboratory, at study
entry and at time of disease progression (or after 24 months of follow-up for non progressed
patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk
(score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly
different clinical courses.
Observational Model: Cohort, Time Perspective: Prospective
Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ).
Fortunato Morabito, MD
Italy: Ethics Committee