Clinical trial NCT04600804: 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 type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mantle Cell Lymphoma
Keywords: prognostic issues
PET review
MCL
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 300 patients have been enrolled in the MCL0208 trial. We expect to analyze the PETs, clinical and biological data of about 200 patients enrolled in the MCL0208 trial who performed the PET exams within the clinical trial and who consent to the present study: all PETs available at each center participating in this study will be collected and analyzed.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy).
timeFrame: 24 months
measure: C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS.
timeFrame: 24months
Secondary outcomes:
Other outcomes:
Locations:
city: Piacenza
country: Italy
facility: U.O.Ematologia Ospedale Guglielmo da Saliceto
state: Emilia Romagna
city: Reggio Emilia
country: Italy
facility: Ematologia Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
state: Emilia Romagna
city: Rimini
country: Italy
facility: U.O. di Ematologia Ospedale degli Infermi di Rimini
state: Emilia Romagna
city: Aviano
country: Italy
facility: S.O.C. Oncologia Medica A Centro Riferimento Oncologico
state: Friuli Venezia Giulia
city: Udine
country: Italy
facility: SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
state: Friuli Venezia Giulia
city: Roma
country: Italy
facility: Ematologia Universitа Cattolica S. Cuore
state: Latium
city: Genova
country: Italy
facility: Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
state: Liguria
city: Genova
country: Italy
facility: U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
state: Liguria
city: Milano
country: Italy
facility: Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
state: Lombardia
city: Milano
country: Italy
facility: SC Ematologia ASST Grande Ospedale Metropolitano Niguarda
state: Lombardia
city: Monza
country: Italy
facility: Ematologia ASST MONZA Ospedale S. Gerardo
state: Lombardia
city: Pavia
country: Italy
facility: Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia
state: Lombardia
city: Rozzano
country: Italy
facility: U.O. Ematologia Istituto Clinico Humanitas
state: Lombardia
city: Brescia
country: Italy
facility: Ematologia ASST Spedali Civili di Brescia
state: Lombardy
city: Milano
country: Italy
facility: Unità Linfomi - Dipartimento Oncoematologia - Istituto Scientifico San Raffaele
state: Milan
city: Alessandria
country: Italy
facility: S.C. Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
state: Piedmont
city: Cuneo
country: Italy
facility: S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle
state: Piedmont
city: Novara
country: Italy
facility: SCDU Ematologia AOU Maggiore della Caritа di Novara
state: Piedmont
city: Turin
country: Italy
facility: Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino
state: Piedmont
city: Turin
country: Italy
facility: S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino
state: Piedmont
city: Lecce
country: Italy
facility: Ematologia Ospedale Vito Fazzi
state: Puglia
city: Tricase
country: Italy
facility: U.O.C Ematologia e Trapianto A.O. C. Panico
state: Puglia
city: Cagliari
country: Italy
facility: SC Ematologia e CTMO Ospedale Businco
state: Sardinia
city: Messina
country: Italy
facility: S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte
state: Sicily
city: Palermo
country: Italy
facility: Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello
state: Sicily
city: Bolzano
country: Italy
facility: Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano
state: Trentino Alto Adige
city: Firenze
country: Italy
facility: Unitа funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi
state: Tuscany
city: Terni
country: Italy
facility: S.C. Oncoematologia A.O. S. Maria di Terni
state: Umbria
city: Treviso
country: Italy
facility: S.C di Ematologia Ospedale Ca Foncello
state: Veneto
city: Verona
country: Italy
facility: U.O. Ematologia AOU Integrata di Verona
state: Veneto
city: Meldola
country: Italy
facility: Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
city: Pisa
country: Italy
facility: U.O. Ematologia - AOU Pisana
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia de Lisboa
Study officials:
affiliation: Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy
name: Michael Mian, MD
role: PRINCIPAL_INVESTIGATOR
References: