Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS
Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance
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.
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.
Rate of mutation
MRD and clonal evolution
Study Arms / Comparison Groups
Description: Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample)
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
August 28, 2018
Primary Completion Date
October 6, 2020
Inclusion Criteria: - Diagnosis of IgM monoclonal gammopathy of undetermined significance (Ig-MGUS) or Waldenström's Macroglobulinemia (WM) according to criteria established at the second International Workshop on Waldenström's Macroglobulinemia  - Age ≥ 18 years - Previously untreated patients (only for the prospective cohort) - Symptomatic or asymptomatic disease - Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) Exclusion Criteria: - Active HBV, HCV or HIV infection (antiHBc+ patients with undetectable HBV-DNA are eligible to the study)
18 Years - N/A
Accepts Healthy Volunteers
Marzia Varettoni, ,
Fondazione Italiana Linfomi ONLUS
Marzia Varettoni, Principal Investigator, Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia