Improving disease understanding and outcome prediction in nodal marginal zone lymphoma
Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma
This study is trying to better understand nodal marginal zone lymphoma by collecting and analyzing patient data and tumor samples from people diagnosed with the disease since 2000.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | International Extranodal Lymphoma Study Group (IELSG) Academic / other |
| Locations | 36 sites (Miami, Florida and 35 other locations) |
| Trial ID | NCT05700149 on ClinicalTrials.gov |
What this trial studies
This international observational cohort study aims to enhance the molecular classification of nodal marginal zone lymphoma (NMZL) by retrospectively collecting coded tumor biological material and health-related patient data from institutional biobanks and medical records. Patients diagnosed with NMZL since January 1, 2000, will be enrolled, and their data will be systematically recorded and analyzed to identify key clinical and biological features. The study will utilize a unique identification code for each patient to ensure data integrity and confidentiality. Follow-up data will also be collected to monitor disease progression and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with NMZL and have available tumor material collected when treatment-naïve.
Not a fit: Patients with nodal spread of clinically occult extranodal marginal zone lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved disease characterization and more accurate outcome predictions for patients with NMZL.
How similar studies have performed: Other studies have shown success in utilizing molecular profiling to improve disease understanding in various lymphomas, indicating a promising approach for this study.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Miami, Florida and 35 other locations
- University of Miami — Miami, Florida, United States (Recruiting)
- Weill Cornell Medical — New York, New York, United States (Recruiting)
- Hematology Center after Prof. Yeolyan — Yerevan, Armenia (Recruiting)
- University Hospital Centre Zagreb — Zagreb, Croatia (Not_yet_recruiting)
- AO SS Antonio e Biagio e C. Arrigo — Alessandria, Al, Italy (Recruiting)
- Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. — Bari, Ba, Italy (Recruiting)
- ASST Papa Giovanni XXIII — Bergamo, Bg, Italy (Not_yet_recruiting)
- ASST degli Spedali Civili di Brescia — Brescia, Bs, Italy (Not_yet_recruiting)
- AOU Policlinico Vittorio Emanuele, Presidio Ferrarotto — Catania, CT, Italy (Recruiting)
- Azienda Ospedaliero Universitaria di Ferrara — Cona, Fe, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Careggi — Florence, Fi, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Papardo — Messina, Me, Italy (Not_yet_recruiting)
- IRCCS Ospedale San Raffaele — Milan, Mi, Italy (Not_yet_recruiting)
- IEO Istituto Europeo di Oncologia — Milan, Mi, Italy (Not_yet_recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milan, Mi, Italy (Not_yet_recruiting)
- Azienda Sanitaria Locale di Pescara — Pescara, Pe, Italy (Not_yet_recruiting)
- Centro di Riferimento Oncologico — Aviano, Pn, Italy (Not_yet_recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pv, Italy (Not_yet_recruiting)
- AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova — Reggio Emilia, Re, Italy (Not_yet_recruiting)
- Fondazione PTV - Policlinico Tor Vergata — Rome, Rm, Italy (Not_yet_recruiting)
- Sapienza University - AOU Policlinico Umberto I — Rome, Rm, Italy (Not_yet_recruiting)
- Fondazione Policlinico Univeristario A. Gemelli, IRCCS, Università Cattolica S. Cuore — Rome, Rm, Italy (Not_yet_recruiting)
- ASST dei Sette Laghi - Ospedale di Circolo di Varese — Varese, VA, Italy (Recruiting)
- IRCCS - Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Federico II — Naples, Italy (Not_yet_recruiting)
- AOU Maggiore della Carità — Novara, Italy (Recruiting)
- Portuguese Institute of Oncology — Lisbon, Portugal (Not_yet_recruiting)
- Chonnam National University Hwasun Hospital — Hwasun-gun, South Korea (Not_yet_recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Oncology Institute of Southern Switzerland and Institute of Oncology Research — Bellinzona, Switzerland (Recruiting)
- Hôpitaux Universitaires Genevois — Geneva, Switzerland (Recruiting)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- University Hospital Zurich — Zurich, Switzerland (Recruiting)
- Leicester Royal Infirmary — Leicester, United Kingdom (Not_yet_recruiting)
- Norfolk and Norwich University Hospital — Norwich, United Kingdom (Not_yet_recruiting)
- Oxford University Hospitals — Oxford, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: IELSG - Study Coordination Office
- Email: ielsg@ior.usi.ch
- Phone: +41586667321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.