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

Sponsor: International Extranodal Lymphoma Study Group (IELSG)

NCT ID: NCT05700149

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 32 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
300
Started
2024-04-11
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for nodal marginal zone lymphoma
  • • Clinical study - 300 participants
  • • International retrospective observational cohort study aimed to describe a molecular classification for NMZL

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with nodal marginal zone lymphoma

Where?

  • • Bournemouth - Royal Bournemouth Hospital
  • • Leicester - Leicester Royal Infirmary
  • • Liverpool - Clatterbridge Cancer Centre Liverpool
  • • Norwich - Norfolk and Norwich University Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Nodal Marginal Zone Lymphoma

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗1\. Nodal spread of a clinically occult extranodal MZL (this must have been ruled out by carefully evaluating the...
See the full 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 Is This Study? (5 UK sites)

Royal Bournemouth Hospital

Bournemouth BH7 7DW, United Kingdom

Recruiting
Site contact (verified)
Renata Walewska, MDPrincipal Investigator

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Constantine Balotis, MDPrincipal Investigator

Clatterbridge Cancer Centre Liverpool

Liverpool L7 8YA, United Kingdom

Recruiting
Site contact (verified)
Andrew Pettitt, MDPrincipal Investigator

Norfolk and Norwich University Hospital

Norwich NR4 7UY, United Kingdom

Recruiting
Site contact (verified)
Victoria Willimott, MDPrincipal Investigator

Oxford University Hospitals

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Danmei Xu, MDPrincipal Investigator

How to Get in Touch

IELSG - Study Coordination Office

Sponsor contact

CONTACT

+41586667321 ielsg@ior.usi.ch

Davide Rossi, MD

Sponsor contact

CONTACT

+41918118540 davide.rossi@eoc.ch
Data sourced from ClinicalTrials.gov · Last verified: 2026-06