Clincosm LogoSign in Get a demo

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

Sponsor
Fondazione Italiana Linfomi ONLUS (Other)
Overall Status
Completed
CT.gov ID
NCT03525665
Collaborator
(none)
175
Enrollment
27
Locations
44
Actual Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Metabolic activity measured by FDG-PET

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 Design

Study Type:
Observational
Actual Enrollment :
175 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Study on the Role of FDG-PET in Patients With Follicular Lymphoma at Time of Relapse/Progression
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Outcome Measures

Primary Outcome Measures

  1. PFS [24 months]

    Progression free survival from time of relapse/progression

Secondary Outcome Measures

  1. OS [24 months]

    Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT Trani BT Italy 70031
2 Azienda Ospedaliera S. Gerardo Di Monza Monza Monza Brianza Italy 20900
3 CROB Rionero in Vulture Potenza Italy 85028
4 Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli" Roma RM Italy 00168
5 Emat Univ - Città della salute e della scienza di Torino Torino TO Italy 10126
6 SOS Ematologia Ospedale C. Massaia Asti Italy 14100
7 A.O. Spedali Civili di Brescia - Ematologia Brescia Italy
8 Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia Catania Italy
9 Az. Ospedaliero Universitaria Careggi Firenze Italy
10 Divisione di Ematologia Ospedale Vito Fazzi Lecce Italy
11 AO Ospedale Civile di Legnano Legnano Italy 20025
12 Ematologia Ospedale Madonna delle Grazie Matera Italy
13 Ospedale Ca' Granda-Niguarda Milano Italy 20162
14 Policlinico di Modena - Università degli studi Modena Italy
15 AOU Maggiore della Carità di Novara - SCDU Ematologia Novara Italy
16 AOU Padova Padova Italy
17 Azienda Ospedaliera V.Cervello Palermo Italy 90146
18 U.O. Ematologia e Centro Trapianto Midollo Osseo - Ospedale G. da Saliceto Piacenza Italy
19 A.O.R. "San Carlo" - U.O. Ematologia Potenza Italy
20 AO Bianchi Melacrino Morelli UO Ematologia Reggio Calabria Italy
21 AO Arcispedale S.Maria Nuova Ematologia Reggio Emilia Italy
22 Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare" Roma Italy
23 Asl Ta Di Taranto Taranto Italy 47014
24 Azienda Ospedaliera "S. Maria" Terni Italy 98158
25 A.O. C. Panico Tricase Italy
26 A.O. Universitaria S. Maria Della Misericordia Di Udine Udine Italy 33100
27 Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI Varese Italy 21100

Sponsors and Collaborators

  • Fondazione Italiana Linfomi ONLUS

Investigators

  • Principal Investigator: Stefano Luminari, Ematologia - AO Arcispedale Santa Maria Nuova - IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT03525665
Other Study ID Numbers:
  • FIL_PETRA
First Posted:
May 16, 2018
Last Update Posted:
Feb 6, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondazione Italiana Linfomi ONLUS
Follicular lymphoma
FDG-PET
Relapse/progression
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Disease Progression
Recurrence

Study Results

No Results Posted as of Feb 6, 2020