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| Name | Class |
|---|---|
| AIL Roma - Italia | UNKNOWN |
| AIL Cuneo - Italia | UNKNOWN |
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This is an observational, multicenter, international and retrospective study, that aims to collect data on clinical and pathological characteristics, treatment regimens, outcome, and prognostic factors (clinical, biomarkers and/or radio-metabolic) in patients affected by PBL.
This study is an International, multicenter, observational, retrospective trial on patients affected by PBL. The information collected aim to obtain data from the real-life diagnosis, staging, management and treatment and outcome of PBL patients. A centralized pathological review of pathological samples is planned to define the rate of accurate diagnosis and to define a recommended immunohistochemical diagnostic panel for PBL. In addition, exploratory analysis will be performed to better characterize PBL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasmablastic lymphoma patients | Patients with diagnosis (histologically confirmed) of plasmablastic lymphoma (PBL) between Jan 1st 2000 and Dec 31st 2022 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the diagnosis to death for any cause or last clinical contact for censored patients. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| ECOG-PS | Proportion of Performance Status: from 0 (fully active) to 4 (Completely disabled) | 36 months |
| Ann Arbor Stage | Proportion of stage: from I (better) to IV (worse) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients (Age ≥ 18 years old) with diagnosis of plasmablastic lymphoma (Histologically confirmed) between Jan 1st 2000, and Dec 31st 2022
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | +390131033153 | startup@filinf.it | |
| Uffici Studi FIL | Contact | +390131033160 | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessia Castellino, MD | UO Ematologia, AO Santa Croce e Carle, Cuneo - Italy | Principal Investigator |
| Emanuele Ravano, MD | UO Ematologia, Niguarda Grande Ospedale Metropolitano, Milano - Italy. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuno-correlati | Recruiting | Aviano | PN | Italy |
Qualified researchers may contact the FIL board at segreteriadirezione@filinf.it to share invidual-level patients' clinical data analysed for the publication article (for the avoidance of doubt, no identifiable data, such as name, address, hospital name, date of birth, or any other identifying data, will be shared and should not be requested).
In compliance with the domestic ethics guideline and applicable legislation, invidual deindentified patients' data underlying the results reported in teh publication article (including study protocol, statistical analysis plan and data coding) can be shared until 5 years after the publication of the present article.
For each data sharing request, it is essential that a proforma (available on request) is completed that describes the general purpose, specific aims, data items requested, analysis plan and acknowledgment of the trial management team. Requests will be reviewed based on scientific merit and ethical principles. Requestors who are granted access to the data will be required to complete a data sharing agreement that will be signed by the requester and FIL.
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| ID | Term |
|---|---|
| D000069293 | Plasmablastic Lymphoma |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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Histological and immunohistochemical slides used for the original diagnosis + block
| 36 months |
| Kidney and/or adrenal gland involvement | Proportion of the presence of involvement | 36 months |
| Diagnostic liquor | Proportion of the presence of liquor | 36 months |
| Splenic involvement | Proportion of spenic involvement | 36 months |
| Type of chemotherapy (CHT) regimen | Proportion of CHT administered | 36 months |
| Complete remission rate (CR) | CR at the end of treatment | 36 months |
| Overall response rate (ORR) | ORR is defined as the proportion of patients who have a partial or complete response to therapy | 36 monts |
| Progression-free survival (PFS) | PFS is defined as time from diagnosis to progression, relapse or death for any cause and last clinical contact for censored cases, | 36 months |
| Validation of IPI and CNS-IPI score by means of Cox PH regression on OS and PFS | IPI (international prognostic Index) ranging from 0 (lower risk) to 5 points (greater risk); CNS-IPI score (Central Nervous System IPI) ranging from 0 (lower risk) to 6 points (greater risk). | 36 months |
| Frequencies of HIV and EBV at relapse | Frequencies of HIV and EBV at relapse | 36 months |
| Ospedale C.e G. Mazzoni, U.O.C. di Ematologia | Recruiting | Ascoli Piceno | Italy |
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| ASST Spedali Civili di Brescia, Ematologia | Not yet recruiting | Brescia | Italy |
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| A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo | Recruiting | Cuneo | Italy |
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| Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia | Recruiting | Florence | Italy |
|
| ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia | Not yet recruiting | Milan | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia | Recruiting | Milan | Italy |
|
| Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia | Recruiting | Milan | Italy |
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| Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia | Not yet recruiting | Milan | Italy |
|
| Fondazione IRCCS San Gerardo dei Tintori, Ematologia | Recruiting | Monza | Italy |
|
| AOU Maggiore della Caritа di Novara, SCDU Ematologia | Recruiting | Novara | Italy |
|
| Azienda Ospedaliera Universitaria di Padova, Ematologia | Not yet recruiting | Padova | Italy |
|
| Presidio ospedaliero A. Tortora, U.O. Onco-ematologia | Not yet recruiting | Pagani | Italy |
|
| Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia | Recruiting | Reggio Emilia | Italy |
|
| Azienda Ospedaliera Universitaria Sant' Andrea, Ematologia | Recruiting | Roma | Italy |
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| Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione | Recruiting | Roma | Italy |
|
| Universitа Cattolica S. Cuore, Ematologia | Not yet recruiting | Roma | Italy |
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| Azienda Ospedaliero Universitaria Senese, U.O.C. Ematologia | Not yet recruiting | Siena | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria | Not yet recruiting | Torino | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia | Not yet recruiting | Torino | Italy |
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| Ospedale S. Chiara, S.S. di Ematologia | Recruiting | Trento | Italy |
|
| ULSS2 Marca Trevigiana, Ospedale Ca' Foncello, S.C di Ematologia | Not yet recruiting | Treviso | Italy |
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| ULSS 8 Berica - Ospedale S. Bortolo, Ematologia | Recruiting | Vicenza | Italy |
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |