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Brief Title: Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS
Official Title: Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance
Study ID: NCT03521596
Brief Summary: Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques.
Detailed Description: Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques such as flow cytometry, real time quantitative PCR (RT-qPCR), digital droplet PCR (dd-PCR) and NGS, in order to: evaluate the mutational status on genomic DNA or cell-free DNA and compare the results to assess the most reliable source for mutation studies; perform and compare molecular and flow cytometry analyses on bone marrow, peripheral blood (both analyses), plasma and urine samples (only molecular analysis) to assess the best source for diagnosis and MRD monitoring.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Divisione di Ematologia Ospedale Niguarda, Milano, MI, Italy
SOS Ematologia Ospedale C. Massaia, Asti, , Italy
IRCCS Istituto Tumori Giovanni Paolo II - UOC Ematologia, Bari, , Italy
AOU Università degli Studi della Campania Luigi Vanvitelli, Napoli, , Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1, Padova, , Italy
A.O. Universitaria Di Parma, Parma, , Italy
Ematologia Policlinico San Matteo, Pavia, , Italy
AO Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, , Italy
Ospedale degli Infermi di Rimini, Rimini, , Italy
Policlinico A. Gemelli Università Cattolica del Sacro Cuore, Roma, , Italy
UOC Ematologia, AOU Senese, Siena, , Italy
A.O. Città della Salute e della Scienza Ematologia Universitaria, Torino, , Italy
Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - PO S. Maria della Misericordia, Udine, , Italy
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI, Varese, , Italy
Name: Marzia Varettoni
Affiliation: Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Role: PRINCIPAL_INVESTIGATOR