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

February 5, 2020 updated by: Fondazione Italiana Linfomi ONLUS

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with relapsed/refractory FL identified by the hematological centers of Italy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 24 months
Progression free survival from time of relapse/progression
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 24 months
Overall survival
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

December 30, 2019

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (ACTUAL)

May 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_PETRA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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