A Cohort Study in Newly Diagnosed MZL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: patients receive optimal treatment or follow-up according to the characteristics of the disease.
- Who it may be relevant to
- Registry conditions: Marginal Zone Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma
Overview
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
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.
Interventions
- 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.
Primary outcome measures
- Progression-free survival [Time frame: assessed up to 10 years]
Secondary outcome measures (7)
- Time to treatment [Time frame: assessed up to 10 years]
- Time to next treatment [Time frame: assessed up to 10 years]
- ORR [Time frame: up to 6 months]
- Overall survival [Time frame: assessed up to 10 years]
- Adverse events [Time frame: Throughout the treatment period, up to 10 years]
- Histologic transformation rate [Time frame: Throughout the study, up to 10 years]
- Occurrence rate of a second tumor [Time frame: Throughout the study, up to 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06449885 · SHCA-MZL-001