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FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role (PIMENTO)

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ClinicalTrials.gov Identifier: NCT04333524
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)

Brief 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.


Condition or disease
Marginal Zone Lymphoma

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role: an International Multicenter Retrospective Analysis
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
Group A
Staging
Group B
Criteria for response assessment



Primary Outcome Measures :
  1. Correlation between CT and PET [ Time Frame: At baseline ]
    To correlate CT and PET results for stage definition

  2. Progression Free Survival (PFS) [ Time Frame: From date of enrollment until the date of first documented progression, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years ]
  3. Duration of Response (DoR) [ Time Frame: 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 ]
    DoR is evaluated only for responding patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  1. 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).
  2. Age over 18.
  3. Availability of details on clinical presentation, treatment details and results, and on follow-up.
  4. Execution of PET at diagnosis or/and at end of treatment or/and at relapse.
  5. Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response.
  6. 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.
  7. Written informed consent.

Exclusion Criteria:

  1. Patients with a diagnosis of Non Hodgkin Lymphoma other than MZL.
  2. Scans images not available for whatever reason.
  3. Cases diagnosed on fine needle aspiration cytology only.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333524


Contacts
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Contact: IELSG - Study Coordination Office +41 91 811 ext 9040 ielsg@eoc.ch
Contact: Stefano Luminari, MD stefano.luminari@ausl.re.it

Locations
Show Show 23 study locations
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
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Study Chair: Stefano Luminari, MD AUSL IRCCS - Reggio Emilia (Italy)
Study Chair: Catherine Thieblemont, MD Saint-Louis Hospital, Paris, France
Study Chair: Emanuele Zucca, MD Oncology Institute of Southern Switzerland
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Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT04333524    
Other Study ID Numbers: IELSG44
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin