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

NCT05700149 · International Extranodal Lymphoma Study Group (IELSG)
In plain English

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About this study
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.
Eligibility criteria
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 design
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-04-11
Estimated completion: 2026-12-31
Last updated: 2026-01-16
Primary outcomes
  • Define and quantify molecular subsets. (Two years: from the end of samples collection to the end of study analysis)
Sponsor
International Extranodal Lymphoma Study Group (IELSG) · other
Contacts & investigators
ContactIELSG - Study Coordination Office · contact · ielsg@ior.usi.ch · +41586667321
ContactDavide Rossi, MD · contact · davide.rossi@eoc.ch · +41918118540
InvestigatorDavide Rossi, MD · study_chair, Oncology Institute of Southern Switzerland and Institute of Oncology Research
All locations (36)
University of MiamiRecruiting
Miami, Florida, United States
Weill Cornell MedicalRecruiting
New York, New York, United States
Hematology Center after Prof. YeolyanRecruiting
Yerevan, Armenia
University Hospital Centre ZagrebNot Yet Recruiting
Zagreb, Croatia
AO SS Antonio e Biagio e C. ArrigoRecruiting
Alessandria, AL, Italy
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.Recruiting
Bari, BA, Italy
ASST Papa Giovanni XXIIINot Yet Recruiting
Bergamo, BG, Italy
ASST degli Spedali Civili di BresciaNot Yet Recruiting
Brescia, BS, Italy
AOU Policlinico Vittorio Emanuele, Presidio FerrarottoRecruiting
Catania, CT, Italy
Azienda Ospedaliero Universitaria di FerraraRecruiting
Cona, FE, Italy
Azienda Ospedaliera Universitaria CareggiNot Yet Recruiting
Florence, FI, Italy
Azienda Ospedaliera PapardoNot Yet Recruiting
Messina, ME, Italy
IRCCS Ospedale San RaffaeleNot Yet Recruiting
Milan, MI, Italy
IEO Istituto Europeo di OncologiaNot Yet Recruiting
Milan, MI, Italy
ASST Grande Ospedale Metropolitano NiguardaNot Yet Recruiting
Milan, MI, Italy
Azienda Sanitaria Locale di PescaraNot Yet Recruiting
Pescara, PE, Italy
Centro di Riferimento OncologicoNot Yet Recruiting
Aviano, PN, Italy
Fondazione IRCCS Policlinico San MatteoNot Yet Recruiting
Pavia, PV, Italy
AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria NuovaNot Yet Recruiting
Reggio Emilia, RE, Italy
Fondazione PTV - Policlinico Tor VergataNot Yet Recruiting
Rome, RM, Italy
Sapienza University - AOU Policlinico Umberto INot Yet Recruiting
Rome, RM, Italy
Fondazione Policlinico Univeristario A. Gemelli, IRCCS, Università Cattolica S. CuoreNot Yet Recruiting
Rome, RM, Italy
ASST dei Sette Laghi - Ospedale di Circolo di VareseRecruiting
Varese, VA, Italy
IRCCS - Azienda Ospedaliero-Universitaria di BolognaNot Yet Recruiting
Bologna, Italy
Azienda Ospedaliera Universitaria Federico IINot Yet Recruiting
Naples, Italy
AOU Maggiore della CaritàRecruiting
Novara, Italy
Portuguese Institute of OncologyNot Yet Recruiting
Lisbon, Portugal
Chonnam National University Hwasun HospitalNot Yet Recruiting
Hwasun-gun, South Korea
University Hospital BaselRecruiting
Basel, Switzerland
Oncology Institute of Southern Switzerland and Institute of Oncology ResearchRecruiting
Bellinzona, Switzerland
Hôpitaux Universitaires GenevoisRecruiting
Geneva, Switzerland
Kantonsspital St. GallenRecruiting
Sankt Gallen, Switzerland
University Hospital ZurichRecruiting
Zurich, Switzerland
Leicester Royal InfirmaryNot Yet Recruiting
Leicester, United Kingdom
Norfolk and Norwich University HospitalNot Yet Recruiting
Norwich, United Kingdom
Oxford University HospitalsNot Yet Recruiting
Oxford, United Kingdom
Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma · TrialPath