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Brief Title: The Role of 18F-FDG-PET for Staging and Prognostication
Official Title: The Role of 18F-FDG-PET for Staging and Prognostication in Patients Enrolled in the Fondazione Italiana Linfomi (FIL) MCL0208 Trial
Study ID: NCT04600804
Brief Summary: A retrospective, multicenter, non-interventional, imaging study ancillary to FIL_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.
Detailed Description: This is a retrospective, multicenter, non-interventional, imaging study devoted to patients diagnosed with MCL and enrolled in the MCL0208 international randomized, phase III clinical trial (NCT02354313). The study is aimed at addressing a number of prognostic issues that still need to be clarified in MCL patients, by taking advantage of the PET performed within the MCL0208 trial and available for the analysis, and the clinical records and molecular data generated in the context of the trial. In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after-ASCT (eot-PET), and none of the exams was used in the decisionmaking strategy. All the PETs available will be collected and considered for analysis. The study will not require additional treatment or procedures except those required for the MCL0208 trial. The participation of the patient to the MCL0208 trial is a pre-requisite to be involved in this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
U.O.Ematologia Ospedale Guglielmo da Saliceto, Piacenza, Emilia Romagna, Italy
Ematologia Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Reggio Emilia, Emilia Romagna, Italy
U.O. di Ematologia Ospedale degli Infermi di Rimini, Rimini, Emilia Romagna, Italy
S.O.C. Oncologia Medica A Centro Riferimento Oncologico, Aviano, Friuli Venezia Giulia, Italy
SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Udine, Friuli Venezia Giulia, Italy
Ematologia Universitа Cattolica S. Cuore, Roma, Latium, Italy
Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia, Genova, Liguria, Italy
U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia, Genova, Liguria, Italy
Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda, Milano, Lombardia, Italy
SC Ematologia ASST Grande Ospedale Metropolitano Niguarda, Milano, Lombardia, Italy
Ematologia ASST MONZA Ospedale S. Gerardo, Monza, Lombardia, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia, Pavia, Lombardia, Italy
U.O. Ematologia Istituto Clinico Humanitas, Rozzano, Lombardia, Italy
Ematologia ASST Spedali Civili di Brescia, Brescia, Lombardy, Italy
Unità Linfomi - Dipartimento Oncoematologia - Istituto Scientifico San Raffaele, Milano, Milan, Italy
S.C. Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Piedmont, Italy
S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle, Cuneo, Piedmont, Italy
SCDU Ematologia AOU Maggiore della Caritа di Novara, Novara, Piedmont, Italy
Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino, Turin, Piedmont, Italy
S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino, Turin, Piedmont, Italy
Ematologia Ospedale Vito Fazzi, Lecce, Puglia, Italy
U.O.C Ematologia e Trapianto A.O. C. Panico, Tricase, Puglia, Italy
SC Ematologia e CTMO Ospedale Businco, Cagliari, Sardinia, Italy
S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte, Messina, Sicily, Italy
Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello, Palermo, Sicily, Italy
Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano, Bolzano, Trentino Alto Adige, Italy
Unitа funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi, Firenze, Tuscany, Italy
S.C. Oncoematologia A.O. S. Maria di Terni, Terni, Umbria, Italy
S.C di Ematologia Ospedale Ca Foncello, Treviso, Veneto, Italy
U.O. Ematologia AOU Integrata di Verona, Verona, Veneto, Italy
Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, , Italy
U.O. Ematologia - AOU Pisana, Pisa, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI), Trieste, , Italy
Instituto Português de Oncologia de Lisboa, Lisboa, , Portugal
Name: Michael Mian, MD
Affiliation: Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy
Role: PRINCIPAL_INVESTIGATOR