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Pee and blood may spare patients painful bone marrow needles

NCT ID NCT03521596

Knowledge-focused Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study looked at 300 people with Waldenström's macroglobulinemia or a related condition to see if blood or urine tests could detect key genetic mutations as accurately as bone marrow biopsies. The goal is to find a less invasive way to monitor the disease over time. Researchers compared mutation rates in blood and urine samples to those from bone marrow to check for agreement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a less invasive way to monitor Waldenström's macroglobulinemia using blood or urine instead of bone marrow biopsies.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The blood/urine tests may not be accurate enough to replace bone marrow biopsies in all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

300 people

The number who actually took part.

Started

Aug 2018

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

monoclonal gammopathy of uncertain significance Neoplasm, Residual Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Waldenstrom macroglobulinemia

Contacts and locations

Locations

  • A.O. Città della Salute e della Scienza Ematologia Universitaria

    Torino, Italy

  • A.O. Universitaria Di Parma

    Parma, 43126, Italy

  • AO Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123, Italy

  • AOU Università degli Studi della Campania Luigi Vanvitelli

    Naples, 80131, Italy

  • Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - PO S. Maria della Misericordia

    Udine, 33100, Italy

  • Divisione di Ematologia Ospedale Niguarda

    Milan, MI, Italy

  • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

    Varese, 21100, Italy

  • Ematologia Policlinico San Matteo

    Pavia, 27100, Italy

  • Hematology Department, Laboratory of Molecular Biology and HLA typing, University Hospital of Salamanca

    Salamanca, Spain

  • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

    Padova, 35128, Italy

  • IRCCS Istituto Tumori Giovanni Paolo II - UOC Ematologia

    Bari, 70124, Italy

  • Ospedale degli Infermi di Rimini

    Rimini, 47924, Italy

  • Policlinico A. Gemelli Università Cattolica del Sacro Cuore

    Roma, 00168, Italy

  • SOS Ematologia Ospedale C. Massaia

    Asti, 14100, Italy

  • UOC Ematologia, AOU Senese

    Siena, 53100, Italy

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