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Brief Title: T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma
Official Title: Prospective Collection of Data in Pts With Peripheral T-Cell Lymphoma: PTCL,NOS;AITL; Extranodal NK/T-cell;Enteropathy-type; Hepatosplenic γ-δ; Subcutaneous Panniculitis-like; ALCL,Primary Systemic Type. By the Intl. T-Cell Lymphoma Project
Study ID: NCT01142674
Brief Summary: The designed study follows up the retrospective previous one by the International T-cell Non-Hodgkin's Lymphoma Study Group (International Peripheral T-Cell Lymphoma Project). It is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and to better define clinical characteristics and outcome of the more uncommon subtypes
Detailed Description: Peripheral T-cell lymphomas (PTCLs) comprise a heterogeneous group of neoplasms that are derived from post-thymic lymphoid cells at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentations. PTCLs are highly diverse, reflecting the diverse cells from which they can originate. Peripheral T-Cell Lymphomas account for 5-10% of all lymphoproliferative disorders in the Western hemisphere, with an overall incidence of 0.5-2 per 100,000 per year, and have a striking epidemiological distribution, with higher incidence in Asia. The clinical features of PTCLs are extremely heterogeneous. PTCLs express even more clinical diversity than B-cell NHLs, and there is a close, though not absolute, relationship between some unusual clinical features and certain histological subtypes. Despite efforts to transferring to patients with T-cell lymphomas the most recent advances in the treatment of other subtypes of B-cell lymphomas, the prognosis of patients with PTCL is still poor an, unfortunately, the optimal therapy for PTCL is still unknown. The complete response rate is rather low, ranging from 40% to 50% with a median Relapse Free Survival (RFS) of 2-3 years. As a consequence of the aggressiveness of the disease and of the low efficacy of available salvage treatments, Overall Survival (OS) is also short and the long-term survival rate is lower than 10% in many series. To better define the clinical outcome of PTCL-NOS, the Intergruppo Italiano Linfomi (IIL, now Fondazione Italiana Linfomi, FIL) performed a large study on 385 patients diagnosed and treated in the 1990s and defined a prognostic model specifically devised for patients with this uncommon disease (Gallamini, A. et al Blood, 2004. 103(7): p. 2474-9). In addition to defining a prognostic model specifically devised for PTCL-NOS, the FIL study confirms the relevance of research on series of clearly defined cases in order to the development of rationally designed and potentially more-efficacious treatment modalities. More recently, the role of biological features of the disease is emerging as an important issue not only for understanding its pathogenesis but also for prognosis and for addressing specific biologic targets altered in the neoplasia. Significant progress in the prognosis of PTCL can be expected from the novel, sophisticated, and powerful technologies of genomics and proteomics, which will allow more reliable subtyping of PTCL into distinct clinical groups characterized by different patterns of survival, as already demonstrated for some B-NHLs. One common limitation of existing studies on prognosis of PTCL is their retrospective nature. Currently available data are based on analysis performed on series collected over a long period of time. This aspect is very important as it may introduce relevant biases in the collected series. First classification systems have changed dramatically over time and cases may have been defined in differently based on diagnosis year. Second some clinical or laboratory data which now are considered as prognostic relevant may have not been determined in older series of patients. Third in a retrospective analysis there is no guarantee that collected series are based on real consecutive cases. These are the reasons why we thought it would be useful to start a new study based on the prospective registration in a short period of time of patients with diagnosis of Peripheral T-cell lymphoma for whom it would be possible collect an exhaustive set of clinical data and biological information.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University Medical Center, Palo Alto, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
St Louis Washington University, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Hospital Italiano, La Plata, Buenos Aires, Argentina
Hospital San Martìn, La Plata, Buenos Aires, Argentina
Fundacion Fundaleu, Buenos Aires, , Argentina
University of Campinas, Campinas, SP, Brazil
Santa Casa Medical School, Sao Paulo, , Brazil
Hospital del Salvador SSMO, Santiago de Chile, , Chile
Princess Margaret Hospital, Hong Kong, , China
Queen Mary Hospital, Hong Kong, , China
Tuen Mun Hospital, Hong Kong, , China
Hopital St Louis, Paris, , France
Sheba Medical Center, Tel-Aviv, , Israel
Sourasky Medical Center, Tel-Aviv, , Israel
Presidio Spedali Civili, Brescia, BS, Italy
Azienda Ospedaliera S. Croce e Carle, Cuneo, CN, Italy
Presidio Ospedaliero Garibaldi-Nesima, Catania, CT, Italy
Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino, Catania, CT, Italy
Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, CZ, Italy
Ospedale Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, FG, Italy
Azienda Ospedaliera Vito Fazzi, Lecce, LE, Italy
Ospedale Civile, Civitanova Marche, Macerata, Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte, Messina, ME, Italy
Istituto Clinico Humanitas, Milano, MI, Italy
Istituto Scientifico Universitario San Raffaele, Milano, MI, Italy
Istituto Europeo di Oncologia, Milano, MI, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Franda, Milano, MI, Italy
Ospedale Madonna delle Grazie, Matera, Mount, Italy
Centro Oncologico Modenese, Modena, MO, Italy
Casa di Cura La Maddalena, Palermo, Pa, Italy
Istituto Oncologico Veneto, Padova, PD, Italy
Centro di Riferimento Oncologico, Aviano, Pordenone, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, RC, Italy
Arcispedale S. Maria Nuova, Reggio Emilia, RE, Italy
Presidio Ospedaliero Umberto I, Nocera Inferiore, SA, Italy
Azienda Ospedaliera S. Giovanni Battista, Torino, TO, Italy
Istituto di Ematologia A & Seragnoli, Bologna, , Italy
Ospedale Centrale di Bolzano, Bolzano, , Italy
Ospedale A. Perrino, Brindisi, , Italy
Ospedale Oncologico A. Businco, Cagliari, , Italy
Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Ospedale Felettino, La Spezia, , Italy
Fondazione Policlinico MaRe IRCCS, Milano, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Azienda Ospedaliera Maggiore della Carità, Novara, , Italy
Azienda Ospedaliero-Universitaria, Parma, , Italy
Ospedale Santo Spirito, Pescara, , Italy
Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Università La Sapienza, Roma, , Italy
Ospedale S. Vincenzo, Taormina, , Italy
Ospedale Moscati, Taranto, , Italy
Azienda Ospedaliera S. Maria, Terni, , Italy
Ospedale Civile SS. Giovanni e Paolo, Venezia, , Italy
Samsung Medical Center, Seoul, , Korea, Republic of
Nacional Cancer Institute, Bratislava, , Slovakia
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario, Salamanca, , Spain
Kantonsspital, Aarau, AG, Switzerland
Ospedale S. Giovanni, Bellinzona, TI, Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
University Hospital Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Barths and The London NHS Trust, London, , United Kingdom
Guy's and St. Thomas NHS Foundation Trust, London, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Newcastle University, Newcastle upon Tyne, , United Kingdom
University of Southampton School of Medicine, Southampton, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Hospital Maciel, Montevideo, , Uruguay
Name: Massimo Federico, MD
Affiliation: Dip. Medicina Diagnostica - Università di Modena e Reggio Emilia, , Modena, IT
Role: STUDY_CHAIR
Name: Julie M. Vose, MD
Affiliation: Nebraska Medical Center, Omaha, NE, USA
Role: STUDY_CHAIR
Name: Emanuele Zucca, MD
Affiliation: IOSI/Oncology Institute of Southern Switzerland, Ospedale S. Giovanni - Bellinzona, CH
Role: STUDY_CHAIR
Name: Joseph M Connors, MD
Affiliation: British Columbia Cancer Agency, Vancouver, CA
Role: STUDY_CHAIR
Name: Steven M. Horwitz, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Name: Francine M. Foss, MD
Affiliation: Yale Cancer Center, New Haven, CT, USA
Role: STUDY_CHAIR
Name: Pier Luigi Zinzani, MD
Affiliation: Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico Sant'Orsola, Bologna, IT
Role: STUDY_CHAIR
Name: Silvia Montoto, MD
Affiliation: St. Bartholomew Hospital, London, UK
Role: STUDY_CHAIR
Name: Aaron Polliack, MD
Affiliation: Sourasky Medical Center, Tel Aviv, IL
Role: STUDY_CHAIR
Name: Stefano A. Pileri, MD
Affiliation: Università di Bologna, IT & Istituto Europeo di Oncologia, Milano, IT
Role: STUDY_CHAIR
Name: Young H. Ko, MD
Affiliation: Samsung Medical Center, Seoul, KR
Role: STUDY_CHAIR