NCT04333524

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
3 countries

25 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Dec 2020Jun 2026

First Submitted

Initial submission to the registry

March 31, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5.5 years

First QC Date

March 31, 2020

Last Update Submit

January 22, 2026

Conditions

Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Correlation between CT and PET

    To correlate CT and PET results for stage definition

    At baseline

Secondary Outcomes (2)

  • Progression Free Survival (PFS)

    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

  • Duration of Response (DoR)

    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

Study Arms (2)

Group A

Staging

Group B

Criteria for response assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

CHU de Dijon

Dijon, 21000, France

Location

Saint Louis Hospital

Paris, France

Location

IUCT Oncopole Toulouse

Toulouse, 31100, France

Location

ASO SS. Antonio e Biagio e C. Arrigo

Alessandria, AL, 15121, Italy

Location

Ospedale degli Infermi

Ponderano, BI, 13875, Italy

Location

Ospedale Oncologico Businco

Cagliari, CA, 09121, Italy

Location

"G. Rodolico", AOU Policlinico Vittorio Emanuele

Catania, CT, 95123, Italy

Location

Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, 20133, Italy

Location

AOU Policlinico "Paolo Giaccone"

Palermo, PA, 90144, Italy

Location

I.R.C.C.S. Istituto Oncologico Veneto

Padua, PD, 35128, Italy

Location

Ospedale Civile Spirito Santo Pescara

Pescara, PE, 65124, Italy

Location

IRCCS Centro di Riferimento Oncologico di Aviano

Aviano, PN, 33081, Italy

Location

Fondazione IRCCS Policlinico S. Matteo di Pavia

Pavia, PV, 27100, Italy

Location

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS

Candiolo, TO, 10060, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino

Torino, TO, 10126, Italy

Location

A.O. Santa Maria di Terni

Terni, TR, 05100, Italy

Location

Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese

Varese, VA, 21100, Italy

Location

Policlinico GB Rossi

Verona, VR, 37134, Italy

Location

IRCCS Istituto Tumori "Giovanni Paolo II"

Bari, 70124, Italy

Location

AOU Federico II

Naples, 80131, Italy

Location

AUSL IRCCS Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Hôpiteux Universitaires de Genève (HUG)

Geneva, Canton of Geneva, 1205, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Bellinzona, Canton Ticino, 6500, Switzerland

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 3, 2020

Study Start

December 1, 2020

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

CH(2)FR(3)IT(20)