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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment | calculate the time interval between the start of diagnosis and the first dose of anti-tumor therapy. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| serum biomarkers | detection of serum DNA biomarkers in the treatment of marginal zone lymphoma | Throughout the study, up to 10 years |
| tissue biomarkers | detection of tissue DNA biomarkers in the treatment of marginal zone lymphoma |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Rong Tao, M.D | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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tumor tissue, peripheral blood samples or bone marrow samples
|
| assessed up to 10 years |
| ORR | the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment | 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 | assessed up to 10 years |
| Adverse events | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Throughout the treatment period, up to 10 years |
| Histologic transformation rate | Proportion of patients with histologic transformation in all patients | Throughout the study, up to 10 years |
| Occurrence rate of a second tumor | Proportion of patients with a second tumor in all patients | Throughout the study, up to 10 years |
| Throughout the study, up to 10 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |