Marginal Zone Lymphoma
Conditions
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.
Interventions
OTHERpatients 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.
Sponsors
Fudan University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| ORR | up to 6 months | the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment |
| 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 |
| Occurrence rate of a second tumor | Throughout the study, up to 10 years | Proportion of patients with a second tumor in all patients |
| Adverse events | Throughout the treatment period, up to 10 years | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| serum biomarkers | Throughout the study, up to 10 years | detection of serum DNA biomarkers in the treatment of marginal zone lymphoma |
| tissue biomarkers | Throughout the study, up to 10 years | detection of tissue DNA biomarkers in the treatment of marginal zone lymphoma |
Countries
China
Contacts
Primary ContactRong Tao, M.D
Backup ContactYizhen Liu, M.D., Ph.D.
Outcome results
None listed