Study on the Role of FDG-PET in Patients With FL at Time of Relapse/Progression
1 other identifier
observational
175
1 country
27
Brief Summary
The study is designed as a retrospective analysis of patients with relapsed/refractory FL identified by the hematological centers of Italy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2016
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFebruary 6, 2020
February 1, 2020
3.7 years
May 3, 2018
February 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
Progression free survival from time of relapse/progression
24 months
Secondary Outcomes (1)
OS
24 months
Interventions
To evaluate whether metabolic activity measured by FDG-PET (SUV max) at time of relapse is predictive of patient's outcome.
Eligibility Criteria
Patients with relapsed/refractory FL identified by the hematological centers of Italy
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT
Trani, BT, 70031, Italy
Azienda Ospedaliera S. Gerardo Di Monza
Monza, Monza Brianza, 20900, Italy
CROB
Rionero in Vulture, Potenza, 85028, Italy
Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli"
Roma, RM, 00168, Italy
Emat Univ - Città della salute e della scienza di Torino
Torino, TO, 10126, Italy
SOS Ematologia Ospedale C. Massaia
Asti, 14100, 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
Florence, Italy
Divisione di Ematologia Ospedale Vito Fazzi
Lecce, Italy
AO Ospedale Civile di Legnano
Legnano, 20025, Italy
Ematologia Ospedale Madonna delle Grazie
Matera, Italy
Ospedale Ca' Granda-Niguarda
Milan, 20162, Italy
Policlinico di Modena - Università degli studi
Modena, Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara, Italy
AOU Padova
Padua, Italy
Azienda Ospedaliera V.Cervello
Palermo, 90146, 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
Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare"
Roma, Italy
Asl Ta Di Taranto
Taranto, 47014, Italy
Azienda Ospedaliera "S. Maria"
Terni, 98158, Italy
A.O. C. Panico
Tricase, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, 33100, Italy
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Varese, 21100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefano Luminari
Ematologia - AO Arcispedale Santa Maria Nuova - IRCCS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 16, 2018
Study Start
May 1, 2016
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
February 6, 2020
Record last verified: 2020-02