A Cohort Study in Newly Diagnosed MZL

NCT ID: NCT06449885

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2034-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Marginal Zone Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Rong Tao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rong Tao, M.D

Role: STUDY_CHAIR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rong Tao, M.D

Role: CONTACT

86-21-64175590

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

Role: CONTACT

86-21-64175590

Facility Contacts

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Rong Tao, MD

Role: primary

8621-64175590

Yizhen Liu, MD

Role: backup

8621-64175590

Other Identifiers

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SHCA-MZL-001

Identifier Type: -

Identifier Source: org_study_id

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