Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of mutations, copy number abnormalities and structural variants at SMZL diagnosis and at HT | 30 months: from the end of samples collection to the end of study analysis | |
| Quantification and qualification of lesions acquired at the time of HT. | 30 months: from the end of samples collection to the end of study analysis | |
| Prevalence of clonal relationship between SMZL and HT | 30 months: from the end of samples collection to the end of study analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of HT molecular subtypes defined by genetic lesions | 30 months: from the end of samples collection to the end of study analysis | |
| Prevalence of Histological Transformation (HT) molecular subtypes defined by gene expression | 30 months: from the end of samples collection to the end of study analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with transformed SMZL
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IELSG Study Coordination Office | Contact | +41 58 666 7321 | ielsg@ior.usi.ch | |
| Davide Rossi, MD | Contact | +41 91 811 8540 | davide.rossi@eoc.ch |
| Name | Affiliation | Role |
|---|---|---|
| Luca Arcaini, MD | Fondazione IRCCS Policlinico San Matteo | Study Chair |
| Davide Rossi, MD | Oncology Institute of Southern Switzerland (IOSI) and Institute of Oncology Research (IOR) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | Not yet recruiting | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Diagnostic tumor material collected at the time of histological transformation (mandatory), from spleen, lymph node, extra-nodal site, peripheral blood or bone marrow. If available, also SMZL diagnostic tumor material (from spleen, peripheral blood and/or bone marrow) collected at the time diagnosis will be collected (not mandatory).
| Prevalence of HT molecular subtypes defined by genetic methylation profile | 30 months: from the end of samples collection to the end of study analysis |
| Prevalence of molecular features in relation with clinical, laboratory and radiological/Positron Emission Tomography (PET) features at SMZL diagnosis and at HT | 30 months: from the end of samples collection to the end of study analysis |
| Universitz Hospitals Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
|
| Hôpital Saint Louis | Recruiting | Paris | 75475 | France |
|
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
|
| Oncology Institute of Southern Switzerland | Not yet recruiting | Bellinzona | 6500 | Switzerland |
|
| University Hospitals Dorset | Not yet recruiting | Bournemouth | BH7 7DW | United Kingdom |
|