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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (5 UK sites)
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Clatterbridge Cancer Centre Liverpool
Liverpool L7 8YA, United Kingdom
Norfolk and Norwich University Hospital
Norwich NR4 7UY, United Kingdom
Oxford University Hospitals
Oxford OX3 7LE, United Kingdom
How to Get in Touch
IELSG - Study Coordination Office
Sponsor contactCONTACT
Davide Rossi, MD
Sponsor contactCONTACT
