The Pathogenesis and Prognostic Factors of Lymphoma

Lymphoma Clinical Trial

Official title:

The Pathogenesis and Prognostic Factors of Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203652
• Other study ID #: SHZS-lym-001
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Peng Liu, Ph.D
• Phone: +862164041990
• Email: liu.peng[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to describe the clinical and genetic characteristics of Chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis.

Description:

Lymphoma is a highly common malignant tumor in Asia. This study aims to observe and describe the clinical and genetic charateristics of Chinese lymphoma patients, and to explore the relationship between those charateristics and pathogenesis and prognostic factors in the real-world population. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with pathological diagnosis of lymphoma (including Hodgkin lymphoma and non-Hodgkin lyphoma, eg. THRLBCL, DLBCL, MZL, CLL/SLL...) from 2007 to 2027.
• Patients with complete diagnostic, treatment and follow-up records.
• Fully comprehension and signature of the informed consent form (ICF) for participation.

Exclusion Criteria:

• Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.
• Severe mental illness.
• Patients deemed unsuitable for inclusion by the investigator.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma

Intervention

Other:
• Real-world regimen
The final personalized management strategy is determined based on current conventional treatment options, physician and patient preferences.The following protocols: chemotherapy, immunochemotherapy,Anti-cd20 monoclonal antibody, BTKi and so on

Locations

Country	Name	City	State
China	Zhongshan Hospital,Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Overall survival (OS) refers to the time from receiving the first dose to death from any cause	Baseline up to data cut-off (Up to approximately 20 years)
Secondary	PFS	Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.	Baseline up to data cut-off (Up to approximately 20 years)