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

December 14, 2023 updated by: Fondazione Italiana Linfomi - ETS

Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Asti, Italy, 14100
        • SOS Ematologia Ospedale C. Massaia
      • Bari, Italy, 70124
        • IRCCS Istituto Tumori Giovanni Paolo II - UOC Ematologia
      • Napoli, Italy, 80131
        • AOU Università degli Studi della Campania Luigi Vanvitelli
      • Padova, Italy, 35128
        • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
      • Parma, Italy, 43126
        • A.O. Universitaria Di Parma
      • Pavia, Italy, 27100
        • Ematologia Policlinico San Matteo
      • Reggio Emilia, Italy, 42123
        • AO Arcispedale Santa Maria Nuova - IRCCS
      • Rimini, Italy, 47924
        • Ospedale degli Infermi di Rimini
      • Roma, Italy, 00168
        • Policlinico A. Gemelli Università Cattolica del Sacro Cuore
      • Siena, Italy, 53100
        • UOC Ematologia, AOU Senese
      • Torino, Italy
        • A.O. Città della Salute e della Scienza Ematologia Universitaria
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - PO S. Maria della Misericordia
      • Varese, Italy, 21100
        • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
    • MI
      • Milano, MI, Italy
        • Divisione di Ematologia Ospedale Niguarda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will include either IgM-MGUS, asymptomatic WM or symptomatic WM patients requiring treatment. Patients in need of therapy will be treated according to recently published guidelines [49]. Patients treated with new agents, including the BTK inhibitor Ibrutinib, will be included. Patient enrolled retrospectively will constitute the learning cohort of the study, while those enrolled prospectively will constitute the validation cohort).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient enrolled
Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample)
Other: MRD and clonal evolution
Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mutation
Time Frame: 22 months
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)
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Marzia Varettoni, Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Actual)

October 6, 2020

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_BIOWM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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