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Spots Global Cancer Trial Database for Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Marzia Varettoni

Affiliation: Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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