Follicular LymphomaNCT03525665
Study on the Role of FDG-PET in Patients With FL at Time of Relapse/Progression
An observational study of Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 27 sites in Italy.
Trial summary
The study is designed as a retrospective analysis of patients with relapsed/refractory FL identified by the hematological centers of Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Metabolic activity measured by FDG-PET
- How many people
- 175 participants
- Where
- 27 sitesItaly
- Study dates
- May 2016to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with relapsed/refractory FL identified by the hematological centers of Italy
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- None
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites
SOS Ematologia Ospedale C. Massaia
Asti, 14100
A.O. Spedali Civili di Brescia - Ematologia
Brescia
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania
Az. Ospedaliero Universitaria Careggi
Florence
Divisione di Ematologia Ospedale Vito Fazzi
Lecce
AO Ospedale Civile di Legnano
Legnano, 20025
Ematologia Ospedale Madonna delle Grazie
Matera
Ospedale Ca' Granda-Niguarda
Milan, 20162
Policlinico di Modena - Università degli studi
Modena
Azienda Ospedaliera S. Gerardo Di Monza
Monza, Monza Brianza, 20900
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara
AOU Padova
Padova
Azienda Ospedaliera V.Cervello
Palermo, 90146
U.O. Ematologia e Centro Trapianto Midollo Osseo - Ospedale G. da Saliceto
Piacenza
A.O.R. "San Carlo" - U.O. Ematologia
Potenza
AO Bianchi Melacrino Morelli UO Ematologia
Reggio Calabria
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia
CROB
Rionero in Vulture, Potenza, 85028
Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli"
Roma, RM, 00168
Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare"
Roma
Asl Ta Di Taranto
Taranto, 47014
Azienda Ospedaliera "S. Maria"
Terni, 98158
Emat Univ - Città della salute e della scienza di Torino
Torino, TO, 10126
U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT
Trani, BT, 70031
A.O. C. Panico
Tricase
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, 33100
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Varese, 21100
About this study
Official title: 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.
Read the 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.
- Conditions
- Follicular Lymphoma
- Being tested
- Metabolic activity measured by FDG-PET
- Keywords
- Follicular lymphoma, FDG-PET, Relapse/progression
- Medical subject headings
- Lymphoma, Follicular, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic activity measured by FDG-PETOther
To evaluate whether metabolic activity measured by FDG-PET (SUV max) at time of relapse is predictive of patient's outcome.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival from time of relapse/progression
Measured: 24 months
Secondary outcomes (1)
OS
Overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study startMay 2016
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Luminari, Principal investigator, Ematologia - AO Arcispedale Santa Maria Nuova - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525665
- Sponsor's protocol ID
- FIL_PETRA
- Status last verified
- Feb 2020
- First submitted
- 3 May 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Role of FDG-PET in Patients With Follicular Lymphoma at Time of Relapse/Progression
- ClinicalTrials.gov ID
- NCT03525665
- Acronym / sponsor ID
- FIL_PETRA
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular lymphoma, FDG-PET, Relapse/progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed as a retrospective analysis of patients with relapsed/refractory FL identified by the hematological centers of Italy.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsed/refractory FL identified by the hematological centers of Italy
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic activity measured by FDG-PETTo evaluate whether metabolic activity measured by FDG-PET (SUV max) at time of relapse is predictive of patient's outcome. | Other | – |
Primary outcome
PFS
Time frame: 24 months
Progression free survival from time of relapse/progression
1 secondary outcome
OS
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Luminari principal investigator
Ematologia - AO Arcispedale Santa Maria Nuova - IRCCS
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 27 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.