A Cohort Study in Newly Diagnosed MZL
- Conditions
- Marginal Zone Lymphoma
- Interventions
- Other: patients receive optimal treatment or follow-up according to the characteristics of the disease
- Registration Number
- NCT06449885
- Lead Sponsor
- Fudan University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2500
- 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.
- Patients with HIV infection.
- Those who cannot come to the hospital regularly for follow-up.
- Those with comorbidities and speech impairment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Newly diagnosed marginal zone lymphoma patients receive optimal treatment or follow-up according to the characteristics of the disease 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.
- Primary Outcome Measures
Name Time Method Progression-free survival assessed up to 10 years 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
- Secondary Outcome Measures
Name Time Method Time to next treatment assessed up to 10 years the time interval from initiation of treatment to initiation of next-line anti-neoplastic therapy or death due to any cause.
Occurrence rate of a second tumor Throughout the study, up to 10 years Proportion of patients with a second tumor in all patients
Time to treatment assessed up to 10 years calculate the time interval between the start of diagnosis and the first dose of anti-tumor therapy.
ORR up to 6 months the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
Adverse events Throughout the treatment period, up to 10 years Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Overall survival assessed up to 10 years time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Histologic transformation rate Throughout the study, up to 10 years Proportion of patients with histologic transformation in all patients
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China