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

June 18, 2026 updated by: International Extranodal Lymphoma Study Group (IELSG)
International retrospective observational cohort study aimed to describe a molecular classification for NMZL.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

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 Contact

  • Name: IELSG - Study Coordination Office
  • Phone Number: +41586667321
  • Email: ielsg@ior.usi.ch

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Hernan Garcia-Rivello, MD
        • Principal Investigator:
          • Hernan Garcia-Rivello, MD
  • Armenia
      • Yerevan, Armenia
        • Recruiting
        • Hematology Center after Prof. Yeolyan
        • Contact:
          • Armine Farmazyan, MD
        • Principal Investigator:
          • Armine Farmazyan
  • Canada
      • Toronto, Canada
        • Recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • John Kuruvilla, MD
        • Contact:
          • John Kuruvilla, MD
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital Centre Zagreb
        • Contact:
          • Igor Aurer, MD
        • Principal Investigator:
          • Igor Aurer, MD
  • France
      • Grenoble, France, 38043
        • Recruiting
        • CHU Grenoble Alpes
        • Contact:
          • Sylvain Carras, MD
        • Principal Investigator:
          • Sylvain Carras
      • Toulouse, France, 31059
        • Recruiting
        • Institut Universitaire du Cancer de Toulouse
        • Contact:
          • Camille Laurent, MD
        • Principal Investigator:
          • Camille Laurent, MD
  • India
      • Mumbai, India
        • Recruiting
        • Tata Memorial Hospital
        • Contact:
          • Manju Sengar, MD
        • Principal Investigator:
          • Manju Sengar, MD
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS - Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
          • Elena Sabattini, MD
        • Principal Investigator:
          • Elena Sabattini, MD
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Contact:
          • Alessandro Severino, MD
        • Principal Investigator:
          • Alessandro Severino, MD
      • Novara, Italy, 28100
        • Recruiting
        • Aou Maggiore Della Carita
        • Principal Investigator:
          • Gianluca Gaidano, MD
        • Contact:
          • Gianluca Gaidano, MD
    • AL
      • Alessandria, AL, Italy, 15121
        • Recruiting
        • AO SS Antonio e Biagio e C. Arrigo
        • Principal Investigator:
          • Gioacchino Catania, MD
        • Contact:
          • Gioacchino Catania, MD
    • BA
      • Bari, BA, Italy, 70124
        • Recruiting
        • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
        • Principal Investigator:
          • Carla Minoia, MD
        • Contact:
          • Carla Minoia, MD
    • BG
      • Bergamo, BG, Italy, 24127
        • Recruiting
        • ASST Papa Giovanni XXIII
        • Contact:
          • Alessandro Rambaldi, MD
        • Principal Investigator:
          • Alessandro Rambaldi, MD
    • BS
      • Brescia, BS, Italy, 25123
        • Recruiting
        • ASST degli Spedali Civili di Brescia
        • Contact:
          • Alessandra Tucci, MD
        • Principal Investigator:
          • Alessandra Tucci, MD
    • CT
      • Catania, CT, Italy, 95123
        • Recruiting
        • AOU Policlinico Vittorio Emanuele, Presidio Ferrarotto
        • Principal Investigator:
          • Amalia Figuera, MD
        • Contact:
          • Amalia Figuera, MD
    • FE
      • Cona, FE, Italy, 44124
        • Recruiting
        • Azienda Ospedaliero Universitaria di Ferrara
        • Contact:
          • Giulia Daghia, MD
        • Principal Investigator:
          • Giulia Daghia, MD
    • FI
      • Florence, FI, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
          • Luca Nassi, MD
        • Principal Investigator:
          • Luca Nassi, MD
    • ME
      • Messina, ME, Italy, 98158
        • Recruiting
        • Azienda Ospedaliera Papardo
        • Principal Investigator:
          • Donato Mannina, MD
        • Contact:
          • Donato Mannina, MD
    • MI
      • Milan, MI, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Maurilio Ponzoni, MD
        • Principal Investigator:
          • Maurilio Ponzoni, MD
      • Milan, MI, Italy, 20162
        • Recruiting
        • Asst Grande Ospedale Metropolitano Niguarda
        • Principal Investigator:
          • Anna Maria Frustaci, MD
        • Contact:
          • Anna Maria Frustaci, MD
      • Milan, MI, Italy, 20141
        • Recruiting
        • IEO Istituto Europeo di Oncologia
        • Principal Investigator:
          • Enrico Derenzini, MD
        • Contact:
          • Enrico Derenzini, MD
    • PE
      • Pescara, PE, Italy, 65124
        • Recruiting
        • Azienda Sanitaria Locale di Pescara
        • Principal Investigator:
          • Elsa Pennese, MD
        • Contact:
          • Elsa Pennese, MD
    • PN
      • Aviano, PN, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico
        • Contact:
          • Michele Spina, MD
        • Principal Investigator:
          • Michele Spina, MD
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Principal Investigator:
          • Luca Arcaini, MD
        • Contact:
          • Luca Arcaini, MD
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Recruiting
        • AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova
        • Contact:
          • Stefano Luminari, MD
        • Principal Investigator:
          • Stefano Luminari, MD
    • RM
      • Rome, RM, Italy, 00133
        • Recruiting
        • Fondazione PTV - Policlinico Tor Vergata
        • Contact:
          • Fabiana Esposito, MD
        • Principal Investigator:
          • Fabiana Esposito, MD
      • Rome, RM, Italy, 00161
        • Recruiting
        • Sapienza University - AOU Policlinico Umberto I
        • Principal Investigator:
          • Ilaria Del Giudice, MD
        • Contact:
          • Ilaria Del Giudice, MD
      • Rome, RM, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Univeristario A. Gemelli, IRCCS, Università Cattolica S. Cuore
        • Contact:
          • Stefan Hohaus, MD
        • Principal Investigator:
          • Stefan Hohaus, MD
    • VA
      • Varese, VA, Italy, 21100
        • Recruiting
        • ASST dei Sette Laghi - Ospedale di Circolo di Varese
        • Contact:
          • Marta Coscia, MD
        • Principal Investigator:
          • Marta Coscia, MD
  • Netherlands
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate Hospital
        • Contact:
          • Michiel van den Brand, MD
        • Principal Investigator:
          • Michiel van den Brand, MD
  • Poland
      • Gdansk, Poland, 80-211
        • Recruiting
        • University Clinical Center, Medical University of Gdansk
        • Contact:
          • Jan Maciej Zaucha, MD
        • Principal Investigator:
          • Jan Maciej Zaucha, MD
  • Portugal
      • Lisbon, Portugal, 1099-023
        • Recruiting
        • Portuguese Institute of Oncology
        • Contact:
          • Maria Gomes Silva, MD
        • Principal Investigator:
          • Maria Gomes Silva, MD
  • South Korea
      • Jeollanam-do, South Korea, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
          • Deok-Hwan Yang, MD
        • Principal Investigator:
          • Deok-Hwan Yang, MD
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Ramón Diez-Feijóo, MD
        • Principal Investigator:
          • Ramón Diez-Feijóo, MD
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic I Provincial de Barcelona
        • Contact:
          • Elias Campo, MD
        • Principal Investigator:
          • Elias Campo, MD
      • L'Hospitalet de Llobregat, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge / Institut Català d'Oncologia
        • Principal Investigator:
          • Eva Domingo, MD
        • Contact:
          • Eva Domingo, MD
  • Switzerland
      • Basel, Switzerland
        • Recruiting
        • University Hospital Basel
        • Contact:
          • Alexandar Tzankov, MD
        • Principal Investigator:
          • Alexandar Tzankov
      • Bellinzona, Switzerland, 6500
        • Recruiting
        • Oncology Institute of Southern Switzerland and Institute of Oncology Research
        • Contact:
          • Maria Cristina Pirosa, MD
        • Principal Investigator:
          • Maria Cristina Pirosa, MD
      • Geneva, Switzerland
        • Recruiting
        • Hôpitaux Universitaires Genevois
        • Contact:
          • Noémie Lang, MD
        • Principal Investigator:
          • Noémie Lang
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Kantonsspital St. Gallen
        • Principal Investigator:
          • Felicitas Hitz, MD
        • Contact:
          • Felicitas Hitz, MD
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
          • Marco Bühler, MD
        • Principal Investigator:
          • Marco Bühler, MD
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Recruiting
        • Royal Bournemouth Hospital
        • Principal Investigator:
          • Renata Walewska, MD
        • Contact:
          • Renata Walewska, MD
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
        • Contact:
          • Constantine Balotis, MD
        • Principal Investigator:
          • Constantine Balotis, MD
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • Clatterbridge Cancer Centre Liverpool
        • Contact:
          • Andrew Pettitt, MD
        • Principal Investigator:
          • Andrew Pettitt, MD
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital
        • Contact:
          • Victoria Willimott, MD
        • Principal Investigator:
          • Victoria Willimott, MD
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Oxford University Hospitals
        • Contact:
          • Danmei Xu, MD
        • Principal Investigator:
          • Danmei Xu, MD
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
          • Jennifer Chapman, MD
        • Principal Investigator:
          • Jennifer Chapman, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Rebecca King, MD
        • Principal Investigator:
          • Rebecca King, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical
        • Principal Investigator:
          • Giorgio Inghirami, MD
        • Contact:
          • Giorgio Inghirami, MD
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Ohio Health Riverside Methodist Hospital
        • Contact:
          • William Basem, MD
        • Principal Investigator:
          • William Basem

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

Patients with diagnosis of NMZL on lymph node histology

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Define and quantify molecular subsets.
Time Frame: Two years: from the end of samples collection to the end of study analysis
Two years: from the end of samples collection to the end of study analysis

Collaborators and Investigators

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

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Investigators

  • Study Chair: Davide Rossi, MD, Oncology Institute of Southern Switzerland and Institute of Oncology Research

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)

April 11, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IELSG52

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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