A Cohort Study in Newly Diagnosed MZL

Marginal Zone Lymphoma Clinical Trial

Official title:

A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449885
• Other study ID #: SHCA-MZL-001
• Status: Recruiting
• Start date: May 30, 2024
• Est. completion date: June 30, 2034

Study information

• Verified date: June 2024
• Source: Fudan University
• Contact: Rong Tao, M.D
• Phone: 86-21-64175590
• Email: rtao[@]shca.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 30, 2034
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Marginal Zone Lymphoma

Intervention

Other:
• patients 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum biomarkers	detection of serum DNA biomarkers in the treatment of marginal zone lymphoma	Throughout the study, up to 10 years
Other	tissue biomarkers	detection of tissue DNA biomarkers in the treatment of marginal zone lymphoma	Throughout the study, up to 10 years
Primary	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
Secondary	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
Secondary	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.	assessed up to 10 years
Secondary	ORR	the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment	up to 6 months
Secondary	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
Secondary	Adverse events	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0	Throughout the treatment period, up to 10 years
Secondary	Histologic transformation rate	Proportion of patients with histologic transformation in all patients	Throughout the study, up to 10 years
Secondary	Occurrence rate of a second tumor	Proportion of patients with a second tumor in all patients	Throughout the study, up to 10 years