A Cohort Study in Newly Diagnosed MZL

NCT06449885 | Recruiting

• 1 other identifier: SHCA-MZL-001
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to treatment

  assessed up to 10 years

• Time to next treatment

  assessed up to 10 years

• ORR

  up to 6 months

• Overall survival

  assessed up to 10 years

• Adverse events

  Throughout the treatment period, up to 10 years

Other Outcomes (2)

• serum biomarkers

  Throughout the study, up to 10 years

• tissue biomarkers

  Throughout the study, up to 10 years

Study Arms (1)

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

Interventions

patients receive optimal treatment or follow-up according to the characteristics of the disease OTHER

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.

Newly diagnosed marginal zone lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue, peripheral blood samples or bone marrow samples

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rong Tao, M.D

  Fudan University

  STUDY CHAIR

Central Study Contacts

Rong Tao, M.D

CONTACT

86-21-64175590; rtao@shca.org.cn

Yizhen Liu, M.D., Ph.D.

CONTACT

86-21-64175590; aliuyz@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 10, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2034
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)