ClinicalTrials.gov record NCT06712459

Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationBelgium, France, Italy, Spain, Switzerland, United Kingdom, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This retrospective observational study collects existing tumor samples and medical record data from adults with transformed Splenic Marginal Zone Lymphoma (t-SMZL). The study analyzes DNA and RNA from those samples to characterize mutations, structural changes, gene expression, and methylation. Its purpose is to better describe the molecular features of t-SMZL and how they relate to clinical course.

What it is studying. The study aims to describe which genetic and molecular changes are present at SMZL diagnosis and at histological transformation, whether the transformed tumor is clonally related to the original SMZL, and what molecular subtypes exist by genetic lesions, gene expression, and DNA methylation. It also looks for relationships between molecular features and clinical, laboratory, and PET findings, plus survival data.

What the researchers hope to learn. To measure how often specific mutations, copy number changes, and structural variants occur at SMZL diagnosis and at transformation; to quantify molecular lesions acquired at transformation; to determine clonal relationships between SMZL and transformed disease; to define molecular subtypes of transformation by genetics, gene expression, and methylation; and to correlate molecular features with clinical, laboratory, and PET findings and survival.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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 disease);
  • 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;
  • Availability of the baseline and follow-up annotations.

Exclusion criteria

  • None

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective study that uses already‑collected tumor samples and medical records. Each participant's information will be given a unique study ID and entered into an electronic case report form. Researchers will work with available tissue or blood samples (for example spleen, lymph node, peripheral blood, or bone marrow samples collected earlier) and will perform laboratory analyses on those samples, including mutation analysis, immunoglobulin gene rearrangement, copy number and structural variant analysis, DNA methylation profiling, and gene expression testing by next‑generation sequencing (NGS) of DNA and RNA. Clinical details such as dates of diagnosis, treatments, progression, and survival will be extracted from charts and linked to the coded samples for analysis.

How the study is structured. This is a retrospective observational cohort study using already existing, coded tumor material and clinical data from biobanks and patient records. Each case is given a unique ID and clinical information is entered into an electronic case report form. Laboratory work includes next-generation sequencing of genomic DNA and RNA to assess mutations, copy number changes, structural variants, DNA methylation profiles, and gene expression. There are no experimental treatments assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Belgium, France, Italy, Spain, Switzerland, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on splenic marginal zone lymphoma

Clinical trials12 trials listed for splenic marginal zone lymphomaEvery trial the registry lists for splenic marginal zone lymphoma, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in splenic marginal zone lymphoma researchLatest monthly update: July 2026. Includes: Slow disease course. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 13, 2025
Primary completion
March 2029 (estimated)
Study completion
March 2029 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Jan 16, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
International Extranodal Lymphoma Study Group (IELSG)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (7)

  • Columbia UniversityNot Yet Recruiting

    New York, New York, 10032 · United States

  • Universitz Hospitals LeuvenNot Yet Recruiting

    Leuven, 3000 · Belgium

  • Hôpital Saint LouisRecruiting

    Paris, 75475 · France

  • Fondazione IRCCS Policlinico San MatteoRecruiting

    Pavia, 27100 · Italy

  • Hospital Clínic de BarcelonaRecruiting

    Barcelona, 08036 · Spain

    • ARMANDO LÓPEZ GUILLERMO, MD
    • · alopezg@clinic.cat
    • Armando Hospital Clínic de Barcelona, MD
  • Oncology Institute of Southern SwitzerlandNot Yet Recruiting

    Bellinzona, 6500 · Switzerland

  • University Hospitals DorsetNot Yet Recruiting

    Bournemouth, BH7 7DW · United Kingdom

Terms used on this page · explanations by MedicalUpdates.ai

overall survival
The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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