Clinical trial NCT06449885: A Cohort Study in Newly Diagnosed MZL
Official title: A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Marginal Zone Lymphoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: assessed up to 10 years
Secondary outcomes:
measure: Time to treatment
timeFrame: assessed up to 10 years
measure: Time to next treatment
timeFrame: assessed up to 10 years
measure: ORR
timeFrame: up to 6 months
measure: Overall survival
timeFrame: assessed up to 10 years
measure: Adverse events
timeFrame: Throughout the treatment period, up to 10 years
measure: Histologic transformation rate
timeFrame: Throughout the study, up to 10 years
measure: Occurrence rate of a second tumor
timeFrame: Throughout the study, up to 10 years
Other outcomes:
measure: serum biomarkers
timeFrame: Throughout the study, up to 10 years
measure: tissue biomarkers
timeFrame: Throughout the study, up to 10 years
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Rong Tao, M.D
role: STUDY_CHAIR
References: