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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 24 months
Progression free survival from time of relapse/progression
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi ONLUS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings