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.
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
2,500
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.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-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
Time frame: assessed up to 10 years
Time to treatment
calculate the time interval between the start of diagnosis and the first dose of anti-tumor therapy.
Time frame: 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.
Time frame: assessed up to 10 years
ORR
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
Time frame: up to 6 months
Overall survival
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Time frame: assessed up to 10 years
Adverse events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Throughout the treatment period, up to 10 years
Histologic transformation rate
Proportion of patients with histologic transformation in all patients
Time frame: Throughout the study, up to 10 years
Occurrence rate of a second tumor
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Proportion of patients with a second tumor in all patients
Time frame: Throughout the study, up to 10 years