FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role: an International Multicenter Retrospective Analysis

Status: Recruiting
Location: See all (25) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

• Age over 18.

• Availability of details on clinical presentation, treatment details and results, and on follow-up.

• Execution of PET at diagnosis or/and at end of treatment or/and at relapse.

• Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response.

• 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.

• Written informed consent.

Locations
Other Locations
France
CHU de Dijon
RECRUITING
Dijon
Saint Louis Hospital
RECRUITING
Paris
IUCT Oncopole Toulouse
RECRUITING
Toulouse
Italy
ASO SS. Antonio e Biagio e C. Arrigo
RECRUITING
Alessandria
IRCCS Centro di Riferimento Oncologico di Aviano
RECRUITING
Aviano
IRCCS Istituto Tumori Giovanni Paolo II
RECRUITING
Bari
Ospedale Oncologico Businco
RECRUITING
Cagliari
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
RECRUITING
Candiolo
G. Rodolico, AOU Policlinico Vittorio Emanuele
RECRUITING
Catania
Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
AOU Federico II
RECRUITING
Napoli
I.R.C.C.S. Istituto Oncologico Veneto
RECRUITING
Padua
AOU Policlinico Paolo Giaccone
RECRUITING
Palermo
Fondazione IRCCS Policlinico S. Matteo di Pavia
RECRUITING
Pavia
Ospedale Civile Spirito Santo Pescara
RECRUITING
Pescara
Ospedale degli Infermi
RECRUITING
Ponderano
AUSL IRCCS Reggio Emilia
RECRUITING
Reggio Emilia
A.O. Santa Maria di Terni
RECRUITING
Terni
A.O.U. Città della Salute e della Scienza di Torino
RECRUITING
Torino
Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese
RECRUITING
Varese
Policlinico GB Rossi
RECRUITING
Verona
Switzerland
Istituto Oncologico della Svizzera Italiana
RECRUITING
Bellinzona
Hôpiteux Universitaires de Genève (HUG)
RECRUITING
Geneva
Contact Information
Primary
IELSG - Study Coordination Office
ielsg@ior.usi.ch
+41 58 666 73
Backup
Stefano Luminari, MD
stefano.luminari@ausl.re.it
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 350
Treatments
Group A
Staging
Group B
Criteria for response assessment
Sponsors
Leads: International Extranodal Lymphoma Study Group (IELSG)

This content was sourced from clinicaltrials.gov

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