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Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma

Sponsor: International Extranodal Lymphoma Study Group (IELSG)

NCT ID: NCT06712459

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 41 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at transformed splenic marginal zone lymphoma, a rare blood cancer where a slow-growing lymphoma changes into a faster-growing type. The research team will study tumour samples and medical records to learn more about the disease at a molecular level. It is run by the International Extranodal Lymphoma Study Group (IELSG).

Who can take part

  • Adults aged 18 or over, any gender
  • A diagnosis of histological transformation of splenic marginal zone lymphoma (at the same time as the original diagnosis, or later during the disease)
  • Availability of stored tumour tissue samples taken at the time of transformation (from the spleen, a lymph node, another site outside the lymph nodes, peripheral blood, or bone marrow); samples from the original diagnosis will also be collected if available
  • Availability of medical records from the start of the disease and during follow-up

Who may not be able to

  • No exclusion criteria are listed — anyone meeting the points above may take part

What taking part involves

  • • Not stated — ask the trial team. This appears to be a study using existing samples and medical records rather than giving a new treatment.

Time commitment: Not stated — ask the trial team about what taking part involves, including any visits or duration.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
100
Started
2025-10-13
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for transformed splenic marginal zone lymphoma
  • • Clinical study - 100 participants
  • • Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced overall survival

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with transformed splenic marginal zone lymphoma

Where?

  • • Bournemouth - University Hospitals Dorset

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

About This Trial

Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced overall survival. At the present time, there are no recommended treatments intended specifically to t-SMZL and little is known about t-SMZL genetic complexity. The aim of this study is to provide information that will help clinicians to better understand the complexity of the disease. The information gained from this study will also lead to more specific and effective treatment for patients with t-SMZL.

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 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. Health-related data will be collected by electronic case report form (e-CRF) system. Data quality will be insured by query generation. Annotated baseline features will include: date of diagnosis, date and tissue type of histological sample collected at diagnosis (spleen and/or bone marrow), age, gender, Eastern Cooperative Oncology Group - Performing Status (ECOG-PS), Ann Arbor stage, Lactate Dehydrogenase (LDH), number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (\>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, Hepatitis C Virus (HCV) infection, serum paraprotein and type. Annotated follow-up features will include: the date of progression to a disease requiring treatment, type of first line treatment, date of start of the first line treatment, date of progression after first line treatment, date of the second line treatment, type of second line treatment. Annotated transformation features will include: date of transformation, date and type of histological sample collected at transformation (spleen and/or bone marrow and/or lymph node and/or other site), histological transformation type and relative molecular data (if available), ECOG-PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (\>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, serum paraprotein, and type. Survival features will include the 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 (NGS) of genomic DNA extracted from the biological sample available for the analysis. Gene expression will be assessed by NGS of RNA extracted from from the biological sample available for the analysis.

Transformed Splenic Marginal Zone Lymphoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

  • ✓Adults aged 18 years or older, regardless of the gender;
  • ✓Diagnosis of HT of SMZL (both at baseline, co-occurring with diagnosis of SMZL, or during the natural history of the...
  • ✓Availability of the baseline and follow-up annotations.
See the full criteria
Inclusion Criteria: 1. Adults aged 18 years or older, regardless of the gender; 2. Diagnosis of HT of SMZL (both at baseline, co-occurring with diagnosis of SMZL, or during the natural history of the disease); 3. Availability of diagnostic tumor material (either frozen or FFPE) from spleen, lymph node, extra nodal site, peripheral blood or bone marrow collected at the time of histological transformation. Tumor material (either frozen or FFPE), from spleen, peripheral blood or bone marrow, collected at the time of SMZL diagnosis will be also collected, if available; 4. Availability of the baseline and follow-up annotations. Exclusion Criteria: * None

Where Is This Study? (1 UK site)

University Hospitals Dorset

Bournemouth BH7 7DW, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Renata Walewska, MDPrincipal Investigator
Renata Walewska, MDRenata.Walewska@uhd.nhs.uk

How to Get in Touch

IELSG Study Coordination Office

Sponsor contact

CONTACT

+41 58 666 7321 ielsg@ior.usi.ch

Davide Rossi, MD

Sponsor contact

CONTACT

+41 91 811 8540 davide.rossi@eoc.ch
Data sourced from ClinicalTrials.gov · Last verified: 2026-01