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Spots Global Cancer Trial Database for T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma

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Trial Identification

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

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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