Clinical trial NCT03525665: Study on the Role of FDG-PET in Patients With FL at Time of Relapse/Progression
Official title: Study on the Role of FDG-PET in Patients With Follicular Lymphoma at Time of Relapse/Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follicular Lymphoma
Keywords: Follicular lymphoma
FDG-PET
Relapse/progression
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with relapsed/refractory FL identified by the hematological centers of Italy

Brief summary: The study is designed as a retrospective analysis of patients with relapsed/refractory FL identified by the hematological centers of Italy.

Detailed description: The study does not require any intervention on the patient, but it involves the simple collection of data that are already present in the medical record. Since this is a retrospective study, it will not require further analysis or diagnostic investigations than those already made.

Eligibility criteria: Inclusion Criteria:

* Patients with initial diagnosis of follicular lymphoma since 2001
* Histological confirmation of follicular lymphoma, grade I, II, III according to WHO 2008 classification, at the time of initial diagnosis
* Systemic first-line treatment with immuno-chemotherapy
* PET availability at the time of response after first-line treatment (optional)
* Clinical and radiological evidence of FL relapse or progression
* Histological confirmation of relapse (strongly recommended)
* PET availability of at the time of relapse/progression and images available for central assessment
* Availability of clinical, laboratory and therapeutic treatment data at the time of initial diagnosis and relapse/progression
* Follow up of at least 12 months after relapse/progression

Exclusion Criteria:

* None

Primary outcomes:
measure: PFS
timeFrame: 24 months
Secondary outcomes:
measure: OS
timeFrame: 24 months
Other outcomes:
Locations:
city: Trani
country: Italy
facility: U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT
state: BT
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo Di Monza
state: Monza Brianza
city: Rionero in Vulture
country: Italy
facility: CROB
state: Potenza
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli"
state: RM
city: Torino
country: Italy
facility: Emat Univ - Città della salute e della scienza di Torino
state: TO
city: Asti
country: Italy
facility: SOS Ematologia Ospedale C. Massaia
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia - Ematologia
city: Catania
country: Italy
facility: Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
city: Firenze
country: Italy
facility: Az. Ospedaliero Universitaria Careggi
city: Lecce
country: Italy
facility: Divisione di Ematologia Ospedale Vito Fazzi
city: Legnano
country: Italy
facility: AO Ospedale Civile di Legnano
city: Matera
country: Italy
facility: Ematologia Ospedale Madonna delle Grazie
city: Milano
country: Italy
facility: Ospedale Ca' Granda-Niguarda
city: Modena
country: Italy
facility: Policlinico di Modena - Università degli studi
city: Novara
country: Italy
facility: AOU Maggiore della Carità di Novara - SCDU Ematologia
city: Padova
country: Italy
facility: AOU Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliera V.Cervello
city: Piacenza
country: Italy
facility: U.O. Ematologia e Centro Trapianto Midollo Osseo - Ospedale G. da Saliceto
city: Potenza
country: Italy
facility: A.O.R. "San Carlo" - U.O. Ematologia
city: Reggio Calabria
country: Italy
facility: AO Bianchi Melacrino Morelli UO Ematologia
city: Reggio Emilia
country: Italy
facility: AO Arcispedale S.Maria Nuova Ematologia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare"
city: Taranto
country: Italy
facility: Asl Ta Di Taranto
city: Terni
country: Italy
facility: Azienda Ospedaliera "S. Maria"
city: Tricase
country: Italy
facility: A.O. C. Panico
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine
city: Varese
country: Italy
facility: Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Study officials:
affiliation: Ematologia - AO Arcispedale Santa Maria Nuova - IRCCS
name: Stefano Luminari
role: PRINCIPAL_INVESTIGATOR
References: