Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS

Fondazione Italiana Linfomi - ETS300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Waldenstrom Macroglobulinemia

Interventions

MRD and clonal evolutionOTHER

Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \[1\] * 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)

Locations (14)

Divisione di Ematologia Ospedale Niguarda

Milan, MI, Italy

SOS Ematologia Ospedale C. Massaia

Asti, Italy

IRCCS Istituto Tumori Giovanni Paolo II - UOC Ematologia

Outcomes

Primary Outcomes

Rate of mutation

To demonstrate that the rate of mutations of MYD88 (L265P) and/or CXCR4 (S338X) detected in peripheral blood and/or urine show a negligible difference with the rate of mutations detected in bone marrow samples (BM, gold standard)

Time frame: 22 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.