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NCT03525665 Clinical Trial

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

Follicular Lymphoma Clinical Trial

Official title:
Study on the Role of FDG-PET in Patients With Follicular Lymphoma at Time of Relapse/Progression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03525665
Other study ID # FIL_PETRA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2016
Est. completion date December 30, 2019

Study information
Verified date February 2020
Source Fondazione Italiana Linfomi ONLUS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Metabolic activity measured by FDG-PET
To evaluate whether metabolic activity measured by FDG-PET (SUV max) at time of relapse is predictive of patient's outcome.

Locations
Country Name City State
Italy SOS Ematologia Ospedale C. Massaia Asti
Italy A.O. Spedali Civili di Brescia - Ematologia Brescia
Italy Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia Catania
Italy Az. Ospedaliero Universitaria Careggi Firenze
Italy Divisione di Ematologia Ospedale Vito Fazzi Lecce
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 Azienda Ospedaliera S. Gerardo Di Monza Monza Monza Brianza
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 A.O.R. "San Carlo" - U.O. Ematologia Potenza
Italy AO Bianchi Melacrino Morelli UO Ematologia Reggio Calabria
Italy AO Arcispedale S.Maria Nuova Ematologia Reggio Emilia
Italy CROB Rionero in Vulture Potenza
Italy Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare" Roma
Italy Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli" Roma RM
Italy Asl Ta Di Taranto Taranto
Italy Azienda Ospedaliera "S. Maria" Terni
Italy Emat Univ - Città della salute e della scienza di Torino Torino TO
Italy U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT Trani BT
Italy A.O. C. Panico Tricase
Italy A.O. Universitaria S. Maria Della Misericordia Di Udine Udine
Italy Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI Varese

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS Progression free survival from time of relapse/progression 24 months
Secondary OS Overall survival 24 months
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