The Role of 18F-FDG-PET for Staging and Prognostication
- Conditions
- Mantle Cell Lymphoma
- Registration Number
- NCT04600804
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Enrollment of the patient in the MCL0208 clinical trial documented by the signature of the study informed consent;
- Patient's treatment in one of the centers that participated in the MCL0208 trial and that has joined the MCL0208-PET study as well;
- Evidence of signed informed consent for the MCL0208-PET study.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy). 24 months To better define the role of PET for the staging of MCL patients at the time of diagnosis, for evaluation of response after induction treatment (pre-ASCT; i-PET) and post ASCT (eot-PET) in comparison to the current standards, namely computed axial tomography (CT) and bone marrow biopsy.
C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS. 24months To build a new prognostic model for PFS, including PET parameters, MIPI-b and biological data (e.g. MRD, GEP and mutational parameters).The achievement of these objectives could help to plan futures studies in order to improve the outcome of MCL patients.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
๐ฎ๐นMilano, Lombardia, Italy
Unitร Linfomi - Dipartimento Oncoematologia - Istituto Scientifico San Raffaele
๐ฎ๐นMilano, Milan, Italy
U.O. Ematologia AOU Integrata di Verona
๐ฎ๐นVerona, Veneto, Italy
Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
๐ฎ๐นMeldola, Italy
S.C. Oncoematologia A.O. S. Maria di Terni
๐ฎ๐นTerni, Umbria, Italy
Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
๐ฎ๐นGenova, Liguria, Italy
S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle
๐ฎ๐นCuneo, Piedmont, Italy
Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino
๐ฎ๐นTurin, Piedmont, Italy
Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello
๐ฎ๐นPalermo, Sicily, Italy
Unitะฐ funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi
๐ฎ๐นFirenze, Tuscany, Italy
S.C. Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
๐ฎ๐นAlessandria, Piedmont, Italy
Instituto Portuguรชs de Oncologia de Lisboa
๐ต๐นLisboa, Portugal
U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
๐ฎ๐นGenova, Liguria, Italy
SCDU Ematologia AOU Maggiore della Caritะฐ di Novara
๐ฎ๐นNovara, Piedmont, Italy
SC Ematologia e CTMO Ospedale Businco
๐ฎ๐นCagliari, Sardinia, Italy
U.O. di Ematologia Ospedale degli Infermi di Rimini
๐ฎ๐นRimini, Emilia Romagna, Italy
S.O.C. Oncologia Medica A Centro Riferimento Oncologico
๐ฎ๐นAviano, Friuli Venezia Giulia, Italy
Ematologia Azienda Unitะฐ Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
๐ฎ๐นReggio Emilia, Emilia Romagna, Italy
U.O.Ematologia Ospedale Guglielmo da Saliceto
๐ฎ๐นPiacenza, Emilia Romagna, Italy
SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
๐ฎ๐นUdine, Friuli Venezia Giulia, Italy
Ematologia Universitะฐ Cattolica S. Cuore
๐ฎ๐นRoma, Latium, Italy
SC Ematologia ASST Grande Ospedale Metropolitano Niguarda
๐ฎ๐นMilano, Lombardia, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia
๐ฎ๐นPavia, Lombardia, Italy
Ematologia ASST MONZA Ospedale S. Gerardo
๐ฎ๐นMonza, Lombardia, Italy
U.O. Ematologia Istituto Clinico Humanitas
๐ฎ๐นRozzano, Lombardia, Italy
Ematologia Ospedale Vito Fazzi
๐ฎ๐นLecce, Puglia, Italy
U.O.C Ematologia e Trapianto A.O. C. Panico
๐ฎ๐นTricase, Puglia, Italy
Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano
๐ฎ๐นBolzano, Trentino Alto Adige, Italy
S.C di Ematologia Ospedale Ca Foncello
๐ฎ๐นTreviso, Veneto, Italy
U.O. Ematologia - AOU Pisana
๐ฎ๐นPisa, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
๐ฎ๐นTrieste, Italy
Ematologia ASST Spedali Civili di Brescia
๐ฎ๐นBrescia, Lombardy, Italy
S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino
๐ฎ๐นTurin, Piedmont, Italy
S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte
๐ฎ๐นMessina, Sicily, Italy