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Nodal Marginal Zone LymphomaNCT05700149

Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma

An observational study of Nodal Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 50 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

International retrospective observational cohort study aimed to describe a molecular classification for NMZL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nodal Marginal Zone Lymphoma
How many people
300 participants
Where
50 sitesin 15 countries
Study dates
11 Apr 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with diagnosis of NMZL on lymph node histology

Who may be able to join

  • Male or female adults 18 years or older
  • Diagnosis of NMZL on lymph node histology after Jan 1st, 2000
  • Availability of tumor material from lymph node (either frozen or FFPE) collected when the patient was treatment naïve
  • Availability of the baseline and follow-up annotations

Who cannot join

  • 1. Nodal spread of a clinically occult extranodal MZL (this must have been ruled out by carefully evaluating the extranodal tissues draining to the involved lymph nodes by imaging or endoscopy)

Trial locations and contacts

50 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

IELSG - Study Coordination Office contact

+41586667321

ielsg@ior.usi.ch

Davide Rossi, MD contact

+41918118540

davide.rossi@eoc.ch

50 sites in 15 countries

Italy22 sites, 22 recruiting

  • AO SS Antonio e Biagio e C. Arrigo

    Alessandria, AL, 15121

    Gioacchino Catania, MD

    Gioacchino Catania, MD

    Recruiting

  • Centro di Riferimento Oncologico

    Aviano, PN, 33081

    Michele Spina, MD

    Michele Spina, MD

    Recruiting

  • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.

    Bari, BA, 70124

    Carla Minoia, MD

    Carla Minoia, MD

    Recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, BG, 24127

    Alessandro Rambaldi, MD

    Alessandro Rambaldi, MD

    Recruiting

  • IRCCS - Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Elena Sabattini, MD

    Elena Sabattini, MD

    Recruiting

  • ASST degli Spedali Civili di Brescia

    Brescia, BS, 25123

    Alessandra Tucci, MD

    Alessandra Tucci, MD

    Recruiting

  • AOU Policlinico Vittorio Emanuele, Presidio Ferrarotto

    Catania, CT, 95123

    Amalia Figuera, MD

    Amalia Figuera, MD

    Recruiting

  • Azienda Ospedaliero Universitaria di Ferrara

    Cona, FE, 44124

    Giulia Daghia, MD

    Giulia Daghia, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, FI, 50134

    Luca Nassi, MD

    Luca Nassi, MD

    Recruiting

  • Azienda Ospedaliera Papardo

    Messina, ME, 98158

    Donato Mannina, MD

    Donato Mannina, MD

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132

    Maurilio Ponzoni, MD

    Maurilio Ponzoni, MD

    Recruiting

  • IEO Istituto Europeo di Oncologia

    Milan, MI, 20141

    Enrico Derenzini, MD

    Enrico Derenzini, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

    Anna Maria Frustaci, MD

    Anna Maria Frustaci, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

    Alessandro Severino, MD

    Alessandro Severino, MD

    Recruiting

  • AOU Maggiore della Carità

    Novara, 28100

    Gianluca Gaidano, MD

    Gianluca Gaidano, MD

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV, 27100

    Luca Arcaini, MD

    Luca Arcaini, MD

    Recruiting

  • Azienda Sanitaria Locale di Pescara

    Pescara, PE, 65124

    Elsa Pennese, MD

    Elsa Pennese, MD

    Recruiting

  • AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova

    Reggio Emilia, RE, 42123

    Stefano Luminari, MD

    Stefano Luminari, MD

    Recruiting

  • Fondazione PTV - Policlinico Tor Vergata

    Rome, RM, 00133

    Fabiana Esposito, MD

    Fabiana Esposito, MD

    Recruiting

  • Sapienza University - AOU Policlinico Umberto I

    Rome, RM, 00161

    Ilaria Del Giudice, MD

    Ilaria Del Giudice, MD

    Recruiting

  • Fondazione Policlinico Univeristario A. Gemelli, IRCCS, Università Cattolica S. Cuore

    Rome, RM, 00168

    Stefan Hohaus, MD

    Stefan Hohaus, MD

    Recruiting

  • ASST dei Sette Laghi - Ospedale di Circolo di Varese

    Varese, VA, 21100

    Marta Coscia, MD

    Marta Coscia, MD

    Recruiting

Other trials in Italy

Switzerland5 sites, 5 recruiting

  • University Hospital Basel

    Basel

    Alexandar Tzankov, MD

    Alexandar Tzankov

    Recruiting

  • Oncology Institute of Southern Switzerland and Institute of Oncology Research

    Bellinzona, 6500

    Maria Cristina Pirosa, MD

    Maria Cristina Pirosa, MD

    Recruiting

  • Hôpitaux Universitaires Genevois

    Geneva

    Noémie Lang, MD

    Noémie Lang

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

    Felicitas Hitz, MD

    Felicitas Hitz, MD

    Recruiting

  • University Hospital Zurich

    Zurich, 8091

    Marco Bühler, MD

    Marco Bühler, MD

    Recruiting

Other trials in Switzerland

United Kingdom5 sites, 5 recruiting

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

    Renata Walewska, MD

    Renata Walewska, MD

    Recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

    Constantine Balotis, MD

    Constantine Balotis, MD

    Recruiting

  • Clatterbridge Cancer Centre Liverpool

    Liverpool, L7 8YA

    Andrew Pettitt, MD

    Andrew Pettitt, MD

    Recruiting

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

    Victoria Willimott, MD

    Victoria Willimott, MD

    Recruiting

  • Oxford University Hospitals

    Oxford, OX3 7LE

    Danmei Xu, MD

    Danmei Xu, MD

    Recruiting

Other trials in United Kingdom

United States4 sites, 4 recruiting

  • Ohio Health Riverside Methodist Hospital

    Columbus, Ohio, 43214

    William Basem, MD

    William Basem

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Jennifer Chapman, MD

    Jennifer Chapman, MD

    Recruiting

  • Weill Cornell Medical

    New York, New York, 10065

    Giorgio Inghirami, MD

    Giorgio Inghirami, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Rebecca King, MD

    Rebecca King, MD

    Recruiting

Other trials in United States

Spain3 sites, 3 recruiting

  • Hospital del Mar

    Barcelona, 08003

    Ramón Diez-Feijóo, MD

    Ramón Diez-Feijóo, MD

    Recruiting

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

    Elias Campo, MD

    Elias Campo, MD

    Recruiting

  • Hospital Universitari de Bellvitge / Institut Català d'Oncologia

    L'Hospitalet de Llobregat, 08907

    Eva Domingo, MD

    Eva Domingo, MD

    Recruiting

Other trials in Spain

France2 sites, 2 recruiting

  • CHU Grenoble Alpes

    Grenoble, 38043

    Sylvain Carras, MD

    Sylvain Carras

    Recruiting

  • Institut Universitaire du Cancer de Toulouse

    Toulouse, 31059

    Camille Laurent, MD

    Camille Laurent, MD

    Recruiting

Other trials in France

Argentina1 site, 1 recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

    Hernan Garcia-Rivello, MD

    Hernan Garcia-Rivello, MD

    Recruiting

Other trials in Argentina

Armenia1 site, 1 recruiting

  • Hematology Center after Prof. Yeolyan

    Yerevan

    Armine Farmazyan, MD

    Armine Farmazyan

    Recruiting

Other trials in Armenia

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto

    John Kuruvilla, MD

    John Kuruvilla, MD

    Recruiting

Other trials in Canada

Croatia1 site, 1 recruiting

  • University Hospital Centre Zagreb

    Zagreb, 10000

    Igor Aurer, MD

    Igor Aurer, MD

    Recruiting

Other trials in Croatia

India1 site, 1 recruiting

  • Tata Memorial Hospital

    Mumbai

    Manju Sengar, MD

    Manju Sengar, MD

    Recruiting

Other trials in India

Netherlands1 site, 1 recruiting

  • Rijnstate Hospital

    Arnhem

    Michiel van den Brand, MD

    Michiel van den Brand, MD

    Recruiting

Other trials in Netherlands

Poland1 site, 1 recruiting

  • University Clinical Center, Medical University of Gdansk

    Gdansk, 80-211

    Jan Maciej Zaucha, MD

    Jan Maciej Zaucha, MD

    Recruiting

Other trials in Poland

Portugal1 site, 1 recruiting

  • Portuguese Institute of Oncology

    Lisbon, 1099-023

    Maria Gomes Silva, MD

    Maria Gomes Silva, MD

    Recruiting

Other trials in Portugal

South Korea1 site, 1 recruiting

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

    Deok-Hwan Yang, MD

    Deok-Hwan Yang, MD

    Recruiting

Other trials in South Korea

About this study

International retrospective observational cohort study aimed to describe a molecular classification for NMZL.

Read the detailed description

Already existing and coded tumor biological material and health-related patient data will be retrospectively collected from institutional biobanks and patients' charts or electronic medical records upon receipt of ethical approval. Each patient enrolled in the study will be assigned to a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data and to label biological samples. The coded biological material will be transferred to the coordinating center at the Oncology Institute of Southern Switzerland and Institute of Oncology Research in Bellinzona. Health-related data will be collected in the eCRF (OpenClinica). Data quality will be insured by query generation.

Annotated baseline features will include date of diagnosis, date of lymph node biopsy, age, gender, ECOG PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, number of nodal sites, B symptoms, lymph nodes larger than 7 cm, Hb, platelets, lymphocytes, beta-2-microglobulin, albumin, HCV infection, serum paraprotein and type.

Annotated follow-up features included date of progression to a disease requiring treatment, type of first line treatment, date of start of first line treatment, date of progression after first line treatment, date of second line treatment, type of second line treatment, date of transformation, date of death, cause of death, date of last follow-up.

Mutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration analysis, structural variant analysis and DNA methylation profile will be performed by next generation sequencing of genomic DNA extracted from the lymph node biopsy. Gene expression will be assessed by next generation sequencing of RNA extracted from the lymph node biopsy.

Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Define and quantify molecular subsets.

    Measured: Two years: from the end of samples collection to the end of study analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start11 Apr 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700149
Sponsor's protocol ID
IELSG52
Status last verified
Jun 2026
First submitted
17 Jan 2023
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Nodal Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 50 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Italy, Switzerland, United Kingdom, United States, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact IELSG - Study Coordination Office (+41586667321, ielsg@ior.usi.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Define and quantify molecular subsets. (time frame: Two years: from the end of samples collection to the end of study analysis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05700149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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