FDG PET-evaluatie voor lymfoom in de marginale zone en de voorspellende rol ervan (PIMENTO)
FDG PET-evaluatie voor lymfoom in de marginale zone en zijn prognostische rol: een internationale multicenter retrospectieve analyse
The general aim of the present study is to assess the role of PET for the staging and for the assessment of response and outcome prediction in Marginal Zone Lymphoma (MZL). This study will be conducted as a multicenter retrospective analysis of MZL for whom PET scan are available as DICOM file for central review.
The study is designed as a retrospective collection of patients with MZL enrolled in the prospective IELSG36 and IELSG38 trials sponsored by IELSG and in the observational NF10 study sponsored by Federazione Italiana Linfomi (FIL), with the possibility to add additional cases from participating institutions.
The study will be conducted on performed scans. No additional scan or procedure will be required for study purposes.
The study will be divided into two sections with different aims:
Part A will be conducted to understand the role of PET for the staging of MZL. PET scans will be analyzed and compared with data retrieved from CT scan and from other staging procedures, also including bone marrow biopsy, ultrasound, and laboratory exams. This part of the study will describe ability of PET to identify pathologic lesions and to contribute to staging definition or to stage migration.
Part B will be conducted to validate standardized criteria for response assessment in MZL including FDG-PET among procedures and to define the prognostic role of metabolic response in MZL. For this purpose the primary endpoint for this part of the study is defined as the progression free survival. Secondary endpoint will be Overall survival, and response rate defined with conventional procedures and rate of histological transformation.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
A significant proportion of patients considered for this study will be retrieved from previous observational prospective clinical studies. Data on clinical presentation, treatment and follow-up will be obtained from the existing dataset of the previous protocols. For the additional cases identified from clinical practice data will be collected from patient chart. A unique study CRF will be prepared to collect all the required details.
Patients with histologically confirmed marginal zone lymphomas according to the current WHO classification are registered in the study. Moreover, patients characteristics (PS, systemic symptoms), Ann Arbor stage, laboratory parameters, serology for hepatitis C, B and human immunodeficiency virus, bone marrow aspirate and biopsy data, data on treatment start and end, chemotherapy details, final response defined according to Cheson 2014 and Matutes criteria, date of last follow-up ,occurrence of any event (relapse, progression, death) with date will be collected.
PET response will be initially coded according to local interpretation of scan report. All FDG-PET, will be then centralized to perform a blinded independent review of staging and response. Images will be centralized and examined by a panel of 3 nuclear medicine physicians that will independently review the scans. Each case will be evaluated by two reviewers. In case of discordant results a third reviewer will adjudicate the case.
Each patient enrolled in the study will be anonymized by assigning a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data.
Anonymized PET data will be uploaded into the DICOM system by the responsible person of the site.
Anonymized health-related data will be collected in the e-CRF. At each site, the responsible of the research or a delegated person will complete the e-CRF.
Only the Study Chair and the Sponsor will have access rights for the health-related data and will be responsible for protection of the data.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Dijon, Frankrijk, 21000
- CHU de Dijon
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Paris, Frankrijk
- Saint Louis Hospital
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Toulouse, Frankrijk, 31100
- IUCT Oncopole Toulouse
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Bari, Italië, 70124
- IRCCS Istituto Tumori "Giovanni Paolo II"
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Naples, Italië, 80131
- AOU Federico II
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Reggio Emilia, Italië, 42123
- AUSL IRCCS Reggio Emilia
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AL
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Alessandria, AL, Italië, 15121
- ASO SS. Antonio e Biagio e C. Arrigo
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BI
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Ponderano, BI, Italië, 13875
- Ospedale degli Infermi
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CA
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Cagliari, CA, Italië, 09121
- Ospedale Oncologico Businco
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CT
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Catania, CT, Italië, 95123
- "G. Rodolico", AOU Policlinico Vittorio Emanuele
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MI
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Milan, MI, Italië, 20132
- Ospedale San Raffaele
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Milan, MI, Italië, 20122
- Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico
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Milan, MI, Italië, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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PA
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Palermo, PA, Italië, 90144
- AOU Policlinico "Paolo Giaccone"
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PD
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Padova, PD, Italië, 35128
- I.R.C.C.S. Istituto Oncologico Veneto
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PE
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Pescara, PE, Italië, 65124
- Ospedale Civile Spirito Santo Pescara
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PN
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Aviano, PN, Italië, 33081
- IRCCS Centro di Riferimento Oncologico di Aviano
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PV
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Pavia, PV, Italië, 27100
- Fondazione IRCCS Policlinico S. Matteo di Pavia
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TO
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Candiolo, TO, Italië, 10060
- Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
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Torino, TO, Italië, 10126
- A.O.U. Città della Salute e della Scienza di Torino
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TR
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Terni, TR, Italië, 05100
- A.O. Santa Maria di Terni
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VA
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Varese, VA, Italië, 21100
- Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese
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VR
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Verona, VR, Italië, 37134
- Policlinico GB Rossi
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Canton Ticino
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Bellinzona, Canton Ticino, Zwitserland, 6500
- Istituto Oncologico della Svizzera Italiana
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Canton of Geneva
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Geneva, Canton of Geneva, Zwitserland, 1205
- Hôpiteux Universitaires de Genève (HUG)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients with MZL enrolled in the prospective IELSG36 and IELSG38 trials and on the observational NF10, with the possibility to add additional cases from participating institutions
Beschrijving
Inclusion Criteria:
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One of the following subtypes of Histology confirmed Indolent non-follicular B-cell lymphoma:
- Splenic MZL (bone marrow histology and/or splenic tissue);
- Extranodal MZL or MALT (tissue biopsy);
- Nodal MZL (lymph node biopsy).
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Age over 18.
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Availability of details on clinical presentation, treatment details and results, and on follow-up.
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Execution of PET at diagnosis or/and at end of treatment or/and at relapse.
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Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response.
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Patients with histologically confirmed marginal zone lymphomas according to the current WHO classification are registered in the study. Diagnosis based on tru-cut core-needle biopsies are permitted in the study.
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Written informed consent.
Exclusion Criteria:
- Patients with a diagnosis of Non Hodgkin Lymphoma other than MZL.
- Scans images not available for whatever reason.
- Cases diagnosed on fine needle aspiration cytology only.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_ONLY
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
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Group A
Staging |
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Group B
Criteria for response assessment |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Correlation between CT and PET
Tijdsspanne: At baseline
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To correlate CT and PET results for stage definition |
At baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Progressievrije overleving (PFS)
Tijdsspanne: Vanaf de datum van inschrijving tot de datum van de eerste gedocumenteerde progressie, of de laatste follow-up, of de datum van overlijden door welke oorzaak dan ook, afhankelijk van wat zich het eerst voordeed, beoordeeld tot een maximum van 10 jaar
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Vanaf de datum van inschrijving tot de datum van de eerste gedocumenteerde progressie, of de laatste follow-up, of de datum van overlijden door welke oorzaak dan ook, afhankelijk van wat zich het eerst voordeed, beoordeeld tot een maximum van 10 jaar
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Duration of Response (DoR)
Tijdsspanne: From date of first response to the date of relapse, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years
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DoR is evaluated only for responding patients |
From date of first response to the date of relapse, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Catherine Thieblemont, MD, Saint-Louis Hospital, Paris, France
- Studie stoel: Stefano Luminari, MD, AUSL IRCCS - Reggio Emilia (Italy)
- Studie stoel: Emanuele Zucca, MD, Oncology Institute of Southern Switzerland
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IELSG44
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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