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

NCT ID: NCT05700149

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-11

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nodal Marginal Zone Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Extranodal Lymphoma Study Group (IELSG)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davide Rossi, MD

Role: STUDY_CHAIR

Oncology Institute of Southern Switzerland and Institute of Oncology Research

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Weill Cornell Medical

New York, New York, United States

Site Status RECRUITING

Hematology Center after Prof. Yeolyan

Yerevan, , Armenia

Site Status RECRUITING

University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status NOT_YET_RECRUITING

AO SS Antonio e Biagio e C. Arrigo

Alessandria, AL, Italy

Site Status RECRUITING

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

Bari, BA, Italy

Site Status RECRUITING

ASST Papa Giovanni XXIII

Bergamo, BG, Italy

Site Status NOT_YET_RECRUITING

ASST degli Spedali Civili di Brescia

Brescia, BS, Italy

Site Status NOT_YET_RECRUITING

AOU Policlinico Vittorio Emanuele, Presidio Ferrarotto

Catania, CT, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria di Ferrara

Cona, FE, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, FI, Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Papardo

Messina, ME, Italy

Site Status NOT_YET_RECRUITING

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Site Status NOT_YET_RECRUITING

IEO Istituto Europeo di Oncologia

Milan, MI, Italy

Site Status NOT_YET_RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

Site Status NOT_YET_RECRUITING

Azienda Sanitaria Locale di Pescara

Pescara, PE, Italy

Site Status NOT_YET_RECRUITING

Centro di Riferimento Oncologico

Aviano, PN, Italy

Site Status NOT_YET_RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy

Site Status NOT_YET_RECRUITING

AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova

Reggio Emilia, RE, Italy

Site Status NOT_YET_RECRUITING

Fondazione PTV - Policlinico Tor Vergata

Rome, RM, Italy

Site Status NOT_YET_RECRUITING

Sapienza University - AOU Policlinico Umberto I

Rome, RM, Italy

Site Status NOT_YET_RECRUITING

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

Rome, RM, Italy

Site Status NOT_YET_RECRUITING

ASST dei Sette Laghi - Ospedale di Circolo di Varese

Varese, VA, Italy

Site Status RECRUITING

IRCCS - Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Site Status NOT_YET_RECRUITING

AOU Maggiore della Carità

Novara, , Italy

Site Status RECRUITING

Portuguese Institute of Oncology

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, , South Korea

Site Status NOT_YET_RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Oncology Institute of Southern Switzerland and Institute of Oncology Research

Bellinzona, , Switzerland

Site Status RECRUITING

Hôpitaux Universitaires Genevois

Geneva, , Switzerland

Site Status RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Leicester Royal Infirmary

Leicester, , United Kingdom

Site Status NOT_YET_RECRUITING

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Site Status NOT_YET_RECRUITING

Oxford University Hospitals

Oxford, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Armenia Croatia Italy Portugal South Korea Switzerland United Kingdom

Central Contacts

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IELSG - Study Coordination Office

Role: CONTACT

+41586667321

Davide Rossi, MD

Role: CONTACT

+41918118540

Facility Contacts

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Jennifer Chapman, MD

Role: primary

Giorgio Inghirami, MD

Role: primary

Armine Farmazyan, MD

Role: primary

Igor Aurer, MD

Role: primary

Gioacchino Catania, MD

Role: primary

Carla Minoia, MD

Role: primary

Alessandro Rambaldi, MD

Role: primary

Alessandra Tucci, MD

Role: primary

Amalia Figuera, MD

Role: primary

Giulia Daghia, MD

Role: primary

Luca Nassi, MD

Role: primary

Donato Mannina, MD

Role: primary

Maurilio Ponzoni, MD

Role: primary

Enrico Derenzini, MD

Role: primary

Anna Maria Frustaci, MD

Role: primary

Elsa Pennese, MD

Role: primary

Michele Spina, MD

Role: primary

Luca Arcaini, MD

Role: primary

Stefano Luminari, MD

Role: primary

Fabiana Esposito, MD

Role: primary

Ilaria Del Giudice, MD

Role: primary

Stefan Hohaus, MD

Role: primary

Marta Coscia, MD

Role: primary

Pier Luigi Zinzani, MD

Role: primary

Alessandro Severino, MD

Role: primary

Gianluca Gaidano, MD

Role: primary

Maria Gomes Silva, MD

Role: primary

Deok-Hwan Yang, MD

Role: primary

Alexandar Tzankov, MD

Role: primary

Maria Cristina Pirosa, MD

Role: primary

Noémie Lang, MD

Role: primary

Felicitas Hitz, MD

Role: primary

Marco Bühler, MD

Role: primary

Constantine Balotis, MD

Role: primary

Victoria Willimott, MD

Role: primary

Danmei Xu, MD

Role: primary

Other Identifiers

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IELSG52

Identifier Type: -

Identifier Source: org_study_id

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