NCT07376330

Brief Summary

Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) is an slow growing malignancy characterized by marked biological and clinical differences across different anatomical sites. Using participants' samples and clinical information, this observational and non-interventional research aims to generate a comprehensive molecular and cellular atlas of MALT lymphoma. The results will enable the identification of biologically meaningful tumor subtypes, microenvironmental niches, and candidate biomarkers with potential relevance for the diagnosis, prognosis, and therapy of MALT lymphoma.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress3%
Apr 2026Dec 2029

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

January 22, 2026

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Molecular and spatial profiles of MALT lymphoma

    Generation of high-resolution molecular and spatial profiles of MALT lymphoma tissues, including annotation of malignant and non-malignant cell populations.

    6 months: from the end of samples collection to the end of study analysis

Secondary Outcomes (2)

  • Creation of a curated multi-omics dataset

    6 months: from the end of samples collection to the end of study analysis

  • Extraction of clinically relevant features using artificial intelligence (AI) from histology sections

    6 months: from the end of samples collection to the end of study analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with diagnosis of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue on histology after Jan 1st, 2000

You may qualify if:

  • Male or female adults 18 years or older
  • Diagnosis of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue on histology after Jan 1st, 2000.
  • Availability of tumor material from biopsies (either frozen or formalin-fixed paraffin-embedded) (FFPE).
  • Availability of the baseline and follow-up annotations.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor material from biopsies, either frozen or formalin-fixed paraffin-embedded

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

  • Luciano Cascione, PhD

    Foundation for the Institute of Oncology Research

    STUDY CHAIR
  • Francesco Bertoni, MD

    Foundation for the Institute of Oncology Research

    STUDY CHAIR

Central Study Contacts

International Extranodal Lymphoma Study Group - IELSG

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Processed molecular data, including single-cell and spatial transcriptomic matrices, cell type annotations, and derived pathway activity scores, will be made available to the scientific community through established public repositories (e.g. GEO, ArrayExpress, or Zenodo), such as controlled-access archives for human genomics data, once primary analyses and initial publications are completed.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
From March 2029 to March 2035
Access Criteria
Raw sequencing data will be deposited where permitted by consent and regulatory frameworks or otherwise shared in controlled-access form to qualified researchers upon reasonable request. Analysis code, computational workflows, and documentation will be shared via publicly accessible version-controlled repositories to ensure transparency and reproducibility

Locations