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| Name | Class |
|---|---|
| Pierre Fabre Pharma AG | INDUSTRY |
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This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD.
The aim of the study is to analyze the clinical features and survival of patients who received a PTLD diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by PTLD, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments.
This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. Retrospective data will be collected for all cases of PTLD diagnosed during a 10 years period since 1st January 2011 to 31th December 2021.
The following clinical characteristics of the patient at the time of PTLD diagnosis and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with histological diagnosis of PTLD | patients with histological diagnosis obtained from a biopsy sample in 10 years' time frame (from 01/01/2011 to 31/12/2021) of PTLD (from allogeneic transplantation (both SOT and HSCT)) |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Overall Survival | survival after PTLD incidence rating | from diagnosis of PTLD to patient's death / last FUP - up to 18 months. |
| clinical and epidemiological features | analyze the clinical and epidemiological features (e.g. positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained) of PTLD patients | from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Progression Free Survival | compare outcomes according to treatment approaches | from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. |
| Overall Response Rate | investigate potential treatment effect modifications on outcomes according to patient characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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Population will be composed by patients with histological diagnosis of PTLD. The following clinical characteristics of the patient at the diagnosis of PTLD and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained.
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| Name | Affiliation | Role |
|---|---|---|
| Federica Cavallo, MD | Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia | Milan | MI | 20122 | Italy | ||
| Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati |
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| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| from treatment of PTLD to patient's death / last FUP - up to 18 months. |
| Complete Response Rate to first and subsequent treatments | investigate potential treatment effect modifications on outcomes according to patient | from treatment of PTLD to patient's death / last FUP - up to 18 months. |
| Overall Survival stratified by prognostic factors | Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant) | from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. |
| Progression Free Survival stratified by prognostic factors | Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant) | from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. |
| Aviano |
| Italy |
| Azienda Ospedaliera Papa Giovanni XXIII - Ematologia | Bergamo | 24127 | Italy |
| A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli" | Bologna | 40138 | Italy |
| A.O. Spedali Civili di Brescia - Ematologia | Brescia | Italy |
| Ospedale Businco - Divisione di Ematologia | Cagliari | Italy |
| A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo | Cuneo | Italy |
| A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia | Florence | 50139 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia | Miano | Italy |
| Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia | Milan | 20132 | Italy |
| AOU Maggiore della Caritа di Novara - SCDU Ematologia | Novara | Italy |
| IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1 | Padova | 35128 | Italy |
| IRCCS Policlinico San Matteo - Divisione di Ematologia | Pavia | Italy |
| Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare | Roma | 00128 | Italy |
| Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia | Roma | 00161 | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia | Roma | Italy |
| AOU Senese - U.O.C. Ematologia | Siena | 53100 | Italy |
| A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia | Torino | 10126 | Italy |
| A.O. Città della Salute e della Scienza - Ematologia Universitaria | Torino | Italy |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica | Udine | 33100 | Italy |
| ULSS 8 Berica - Ospedale S. Bortolo - Ematologia | Vicenza | 36100 | Italy |