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
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.
Study Type
Observational
Primary Outcome
Rate of mutation
Condition
Waldenstrom Macroglobulinemia
Intervention
MRD and clonal evolution
Study Arms / Comparison Groups
Patient enrolled
Description: Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
300
Start Date
August 28, 2018
Completion Date
December 2022
Primary Completion Date
October 6, 2020
Eligibility Criteria
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Marzia Varettoni, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT03521596
Organization ID
FIL_BIOWM
Responsible Party
Sponsor
Study Sponsor
Fondazione Italiana Linfomi ONLUS
Study Sponsor
Marzia Varettoni, Principal Investigator, Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Verification Date
November 2022