A Cohort Study in Newly Diagnosed MZL

A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma

Describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of marginal zone B-cell lymphoma (MZL), observe the therapeutic efficacy and safety of different treatment modalities.

Study Overview

• Status: Recruiting
• Conditions: Marginal Zone Lymphoma
• Intervention / Treatment: Other: patients receive optimal treatment or follow-up according to the characteristics of the disease

Detailed Description

Marginal zone lymphoma (MZL) originates from the marginal zone of lymphatic follicles and can occur in the spleen, lymph nodes and mucosal lymphoid tissues, and the incidence increases with age. The clinicopathological features of each subtype of MZL are heterogeneous, and their clinical manifestations, biology, etiology, and treatment are all quite heterogeneous, and there is still significant uncertainty about the optimal treatment pathway. This prospective, multicenter, cohort study aims to describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of MZL, and to observe the therapeutic efficacy and safety of different treatment modalities.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Rong Tao, M.D; Phone Number: 86-21-64175590; Email: rtao@shca.org.cn
• Study Contact Backup: Name: Yizhen Liu, M.D., Ph.D.; Phone Number: 86-21-64175590; Email: aliuyz@126.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: Rong Tao, MD
      • Contact: Rong Tao, MD; Phone Number: 8621-64175590; Email: rtao@shca.org.cn
      • Contact: Yizhen Liu, MD; Phone Number: 8621-64175590; Email: aliuyz@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed marginal zone lymphoma who are eligible for enrollment will be evaluated by the investigator and the enrolled patients will receive long-term follow-up after collecting medical history information, biological samples, and oncology data according to the study protocol.

Description

Inclusion Criteria:

• Age≥ 18 years old; Male or female.
• Newly diagnosed marginal zone lymphoma by histopathology within the past 6 months (180 days) and no anti-tumor therapy (including chemotherapy, radiotherapy, and biological therapy or immunotherapy for the treatment of tumors).
• Willing to provide biological samples required for the study, including blood samples and tumor tissue.
• Voluntarily join this study and sign the informed consent form.
• Willing to accept long-term follow-up.

Exclusion Criteria:

• Patients with HIV infection.
• Those who cannot come to the hospital regularly for follow-up.
• Those with comorbidities and speech impairment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Newly diagnosed marginal zone lymphoma; Newly diagnosed marginal zone lymphoma，including Mucosa-associated lymphoid tissue (MALT) lymphoma, spleen MZL, and lymph node MZL, as well as primary cutaneous MZL, and pediatric NMZL.

Other: patients receive optimal treatment or follow-up according to the characteristics of the disease; Patients with MZL who are eligible for enrollment will be evaluated by the investigator and the enrolled patients will receive long-term follow-up after collecting medical history information, biological samples, and oncology data according to the study protocol. This study does not specify a detailed treatment modality, and patients receive optimal treatment or follow-up according to the characteristics of the disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	record the period from date of patients sign informed consent until the date of documented progression or date of death from any cause, whichever came first	assessed up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment	up to 6 months
Time to treatment	calculate the time interval between the start of diagnosis and the first dose of anti-tumor therapy.	assessed up to 10 years
Time to next treatment	the time interval from initiation of treatment to initiation of next-line anti-neoplastic therapy or death due to any cause.	assessed up to 10 years
Overall survival	time between the date of patients sign informed consent and the date of death or the date of last follow-up time	assessed up to 10 years
Adverse events	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0	Throughout the treatment period, up to 10 years
Histologic transformation rate	Proportion of patients with histologic transformation in all patients	Throughout the study, up to 10 years
Occurrence rate of a second tumor	Proportion of patients with a second tumor in all patients	Throughout the study, up to 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum biomarkers	detection of serum DNA biomarkers in the treatment of marginal zone lymphoma	Throughout the study, up to 10 years
tissue biomarkers	detection of tissue DNA biomarkers in the treatment of marginal zone lymphoma	Throughout the study, up to 10 years

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Chair: Rong Tao, M.D, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2034

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, B-Cell, Marginal Zone
• Other Study ID Numbers: SHCA-MZL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No