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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03521596 |
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Date of registration:
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30/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS
FIL_BIOWM |
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Scientific title:
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Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance |
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Date of first enrolment:
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August 28, 2018 |
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Target sample size:
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300 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03521596 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Marzia Varettoni |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Waldenstrom Macroglobulinemia
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Intervention(s)
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Other: MRD and clonal evolution
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Primary Outcome(s)
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Rate of mutation
[Time Frame: 22 months]
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Secondary ID(s)
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FIL_BIOWM
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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