Study on the Role of FDG-PET in Patients With FL at Time of Relapse/Progression

Completed

• Conditions: Follicular Lymphoma

• Registration Number: NCT03525665
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	24 months	Progression free survival from time of relapse/progression

Secondary Outcome Measures

Name	Time	Method
OS	24 months	Overall survival

Trial Locations

Locations (27)

Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli"; 🇮🇹 Roma, RM, Italy

SOS Ematologia Ospedale C. Massaia; 🇮🇹 Asti, Italy

A.O. Spedali Civili di Brescia - Ematologia; 🇮🇹 Brescia, Italy

A.O. Universitaria S. Maria Della Misericordia Di Udine; 🇮🇹 Udine, Italy

Az. Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

Divisione di Ematologia Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

Asl Ta Di Taranto; 🇮🇹 Taranto, Italy

Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare"; 🇮🇹 Roma, Italy

Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI; 🇮🇹 Varese, Italy

A.O. C. Panico; 🇮🇹 Tricase, Italy

U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT; 🇮🇹 Trani, BT, Italy

Azienda Ospedaliera S. Gerardo Di Monza; 🇮🇹 Monza, Monza Brianza, Italy

CROB; 🇮🇹 Rionero in Vulture, Potenza, Italy

Emat Univ - Città della salute e della scienza di Torino; 🇮🇹 Torino, TO, Italy

Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia; 🇮🇹 Catania, Italy

AO Ospedale Civile di Legnano; 🇮🇹 Legnano, Italy

Ematologia Ospedale Madonna delle Grazie; 🇮🇹 Matera, Italy

Ospedale Ca' Granda-Niguarda; 🇮🇹 Milano, Italy

Policlinico di Modena - Università degli studi; 🇮🇹 Modena, Italy

AOU Maggiore della Carità di Novara - SCDU Ematologia; 🇮🇹 Novara, Italy

AOU Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliera V.Cervello; 🇮🇹 Palermo, Italy

U.O. Ematologia e Centro Trapianto Midollo Osseo - Ospedale G. da Saliceto; 🇮🇹 Piacenza, Italy

AO Bianchi Melacrino Morelli UO Ematologia; 🇮🇹 Reggio Calabria, Italy

A.O.R. "San Carlo" - U.O. Ematologia; 🇮🇹 Potenza, Italy

AO Arcispedale S.Maria Nuova Ematologia; 🇮🇹 Reggio Emilia, Italy

Azienda Ospedaliera "S. Maria"; 🇮🇹 Terni, Italy