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
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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RECRUITING
300 participants
OBSERVATIONAL
2024-04-11
2026-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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International Extranodal Lymphoma Study Group (IELSG)
OTHER
Responsible Party
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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
Weill Cornell Medical
New York, New York, United States
Hematology Center after Prof. Yeolyan
Yerevan, , Armenia
University Hospital Centre Zagreb
Zagreb, , Croatia
AO SS Antonio e Biagio e C. Arrigo
Alessandria, AL, Italy
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
Bari, BA, Italy
ASST Papa Giovanni XXIII
Bergamo, BG, Italy
ASST degli Spedali Civili di Brescia
Brescia, BS, Italy
AOU Policlinico Vittorio Emanuele, Presidio Ferrarotto
Catania, CT, Italy
Azienda Ospedaliero Universitaria di Ferrara
Cona, FE, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, FI, Italy
Azienda Ospedaliera Papardo
Messina, ME, Italy
IRCCS Ospedale San Raffaele
Milan, MI, Italy
IEO Istituto Europeo di Oncologia
Milan, MI, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy
Azienda Sanitaria Locale di Pescara
Pescara, PE, Italy
Centro di Riferimento Oncologico
Aviano, PN, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy
AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova
Reggio Emilia, RE, Italy
Fondazione PTV - Policlinico Tor Vergata
Rome, RM, Italy
Sapienza University - AOU Policlinico Umberto I
Rome, RM, Italy
Fondazione Policlinico Univeristario A. Gemelli, IRCCS, Università Cattolica S. Cuore
Rome, RM, Italy
ASST dei Sette Laghi - Ospedale di Circolo di Varese
Varese, VA, Italy
IRCCS - Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
AOU Maggiore della Carità
Novara, , Italy
Portuguese Institute of Oncology
Lisbon, , Portugal
Chonnam National University Hwasun Hospital
Hwasun-gun, , South Korea
University Hospital Basel
Basel, , Switzerland
Oncology Institute of Southern Switzerland and Institute of Oncology Research
Bellinzona, , Switzerland
Hôpitaux Universitaires Genevois
Geneva, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Leicester Royal Infirmary
Leicester, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Oxford University Hospitals
Oxford, , United Kingdom
Countries
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Central Contacts
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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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