Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobuli… (NCT03521596) | Clinical Trial Compass
CompletedNot Applicable
Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS
Italy300 participantsStarted 2018-08-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)