Blood and Lymph Conditions

Immune System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Monoclonal Gammopathy of Undetermined Significance

Neoplasm, Residual

Waldenstrom Macroglobulinemia

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample)

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

MRD and clonal evolution

Marzia Varettoni

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.

Peripheral blood, Bone marrow and Urine collected at Baseline, Before treatment, after treatment, at 12 months follow up, at 24 months follow up and at 60 months follow up

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

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)

Fondazione Italiana Linfomi - ETS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS	NCT03521596	Waldenstrom Mac...	MRD and clonal ...	18 Years -	Fondazione Italiana Linfomi - ETS
Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS	NCT03521596	Waldenstrom Mac...	MRD and clonal ...	18 Years -	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for mrd and clonal evolution