NCT05700149

Brief Summary

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
8 countries

36 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 11, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 17, 2023

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Define and quantify molecular subsets.

    Two years: from the end of samples collection to the end of study analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diagnosis of NMZL on lymph node histology

You may qualify if:

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

You may not qualify if:

  • \. 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Weill Cornell Medical

New York, New York, 10065, United States

RECRUITING

Hematology Center after Prof. Yeolyan

Yerevan, Armenia

RECRUITING

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

NOT YET RECRUITING

AO SS Antonio e Biagio e C. Arrigo

Alessandria, AL, 15121, Italy

RECRUITING

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

Bari, BA, 70124, Italy

RECRUITING

ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

NOT YET RECRUITING

ASST degli Spedali Civili di Brescia

Brescia, BS, 25123, Italy

NOT YET RECRUITING

AOU Policlinico Vittorio Emanuele, Presidio Ferrarotto

Catania, CT, 95123, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Ferrara

Cona, FE, 44124, Italy

RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, FI, 50134, Italy

NOT YET RECRUITING

Azienda Ospedaliera Papardo

Messina, ME, 98158, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

NOT YET RECRUITING

IEO Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, 20162, Italy

NOT YET RECRUITING

Azienda Sanitaria Locale di Pescara

Pescara, PE, 65124, Italy

NOT YET RECRUITING

Centro di Riferimento Oncologico

Aviano, PN, 33081, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

NOT YET RECRUITING

AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova

Reggio Emilia, RE, 42123, Italy

NOT YET RECRUITING

Fondazione PTV - Policlinico Tor Vergata

Rome, RM, 00133, Italy

NOT YET RECRUITING

Sapienza University - AOU Policlinico Umberto I

Rome, RM, 00161, Italy

NOT YET RECRUITING

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

Rome, RM, 00168, Italy

NOT YET RECRUITING

ASST dei Sette Laghi - Ospedale di Circolo di Varese

Varese, VA, 21100, Italy

RECRUITING

IRCCS - Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

NOT YET RECRUITING

AOU Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Portuguese Institute of Oncology

Lisbon, 1099-023, Portugal

NOT YET RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, 58128, South Korea

NOT YET RECRUITING

University Hospital Basel

Basel, Switzerland

RECRUITING

Oncology Institute of Southern Switzerland and Institute of Oncology Research

Bellinzona, 6500, Switzerland

RECRUITING

Hôpitaux Universitaires Genevois

Geneva, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

NOT YET RECRUITING

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

NOT YET RECRUITING

Oxford University Hospitals

Oxford, OX3 7LE, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biological material of patients with diagnosis of NMZL

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Davide Rossi, MD

    Oncology Institute of Southern Switzerland and Institute of Oncology Research

    STUDY CHAIR

Central Study Contacts

IELSG - Study Coordination Office

CONTACT

Davide Rossi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

April 11, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations