Évaluation de la TEP au FDG pour le lymphome de la zone marginale et son rôle pronostique (PIMENTO)
Évaluation de la TEP au FDG pour le lymphome de la zone marginale et son rôle pronostique : une analyse rétrospective multicentrique internationale
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Dijon, France, 21000
- CHU de Dijon
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Paris, France
- Saint Louis Hospital
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Toulouse, France, 31100
- IUCT Oncopole Toulouse
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Bari, Italie, 70124
- IRCCS Istituto Tumori "Giovanni Paolo II"
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Naples, Italie, 80131
- AOU Federico II
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Reggio Emilia, Italie, 42123
- AUSL IRCCS Reggio Emilia
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AL
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Alessandria, AL, Italie, 15121
- ASO SS. Antonio e Biagio e C. Arrigo
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BI
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Ponderano, BI, Italie, 13875
- Ospedale degli Infermi
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CA
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Cagliari, CA, Italie, 09121
- Ospedale Oncologico Businco
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CT
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Catania, CT, Italie, 95123
- "G. Rodolico", AOU Policlinico Vittorio Emanuele
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MI
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Milan, MI, Italie, 20132
- Ospedale San Raffaele
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Milan, MI, Italie, 20122
- Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico
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Milan, MI, Italie, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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PA
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Palermo, PA, Italie, 90144
- AOU Policlinico "Paolo Giaccone"
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PD
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Padova, PD, Italie, 35128
- I.R.C.C.S. Istituto Oncologico Veneto
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PE
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Pescara, PE, Italie, 65124
- Ospedale Civile Spirito Santo Pescara
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PN
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Aviano, PN, Italie, 33081
- IRCCS Centro di Riferimento Oncologico di Aviano
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PV
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Pavia, PV, Italie, 27100
- Fondazione IRCCS Policlinico S. Matteo di Pavia
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TO
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Candiolo, TO, Italie, 10060
- Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
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Torino, TO, Italie, 10126
- A.O.U. Città della Salute e della Scienza di Torino
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TR
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Terni, TR, Italie, 05100
- A.O. Santa Maria di Terni
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VA
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Varese, VA, Italie, 21100
- Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese
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VR
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Verona, VR, Italie, 37134
- Policlinico GB Rossi
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Canton Ticino
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Bellinzona, Canton Ticino, Suisse, 6500
- Istituto Oncologico della Svizzera Italiana
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Canton of Geneva
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Geneva, Canton of Geneva, Suisse, 1205
- Hôpiteux Universitaires de Genève (HUG)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: RETROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
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Group A
Staging |
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Group B
Criteria for response assessment |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Correlation between CT and PET
Délai: At baseline
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To correlate CT and PET results for stage definition |
At baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Survie sans progression (PFS)
Délai: De la date d'inscription jusqu'à la date de la première progression documentée, ou du dernier suivi, ou de la date du décès, quelle qu'en soit la cause, selon la première éventualité, évaluée jusqu'à un maximum de 10 ans
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De la date d'inscription jusqu'à la date de la première progression documentée, ou du dernier suivi, ou de la date du décès, quelle qu'en soit la cause, selon la première éventualité, évaluée jusqu'à un maximum de 10 ans
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Duration of Response (DoR)
Délai: 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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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Catherine Thieblemont, MD, Saint-Louis Hospital, Paris, France
- Chaise d'étude: Stefano Luminari, MD, AUSL IRCCS - Reggio Emilia (Italy)
- Chaise d'étude: Emanuele Zucca, MD, Oncology Institute of Southern Switzerland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IELSG44
Informations sur les médicaments et les dispositifs, documents d'étude
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