Integrated molecular and clinical profiling of transformed splenic marginal zone lymphoma
Collect tumor samples and medical records from adults with transformed splenic marginal zone lymphoma to try to uncover genetic and clinical patterns that could lead to better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | International Extranodal Lymphoma Study Group (IELSG) Academic / other |
| Locations | 7 sites (New York, New York and 6 other locations) |
| Trial ID | NCT06712459 on ClinicalTrials.gov |
What this trial studies
This is a retrospective observational project that collects existing coded tumor material (frozen or FFPE) and linked clinical data from institutional biobanks and medical records after ethical approval. Each patient will receive a unique ID code and annotated baseline and follow-up clinical features will be entered into an electronic case report form with quality checks. Molecular profiling will be performed on available diagnostic and transformation-time tumor samples to characterize genetic complexity alongside clinical course and treatments. The combined molecular and clinical dataset aims to define patterns associated with histological transformation and outcomes in t-SMZL.
Who should consider this trial
Good fit: Adults aged 18 or older with histologically confirmed transformation of SMZL and available diagnostic tumor material and baseline and follow-up clinical annotations are eligible.
Not a fit: Patients without available tumor tissue or with incomplete baseline or follow-up records are unlikely to contribute usable data and thus may not benefit from participation.
Why it matters
Potential benefit: If successful, the work could identify genetic drivers and clinical markers that help clinicians choose more specific and effective treatments for patients with transformed SMZL.
How similar studies have performed: Genomic and clinical profiling has produced useful insights in other lymphoma subtypes, but comprehensive molecular data specifically for transformed SMZL are limited, so this approach is relatively novel for this disease.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
New York, New York and 6 other locations
- Columbia University — New York, New York, United States (Not_yet_recruiting)
- Universitz Hospitals Leuven — Leuven, Belgium (Not_yet_recruiting)
- Hôpital Saint Louis — Paris, France (Recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
- Oncology Institute of Southern Switzerland — Bellinzona, Switzerland (Not_yet_recruiting)
- University Hospitals Dorset — Bournemouth, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: IELSG Study Coordination Office
- Email: ielsg@ior.usi.ch
- Phone: +41 58 666 7321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.