The Pathogenesis and Prognostic Factors of Lymphoma

January 2, 2024 updated by: Peng Liu, Shanghai Zhongshan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital，Fudan University
        • Contact:
        • Principal Investigator:
          • Peng Liu, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pathological diagnosis of lymphoma from 2007 to 2027 according to 2016 WHO classification.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All enrolled patients
All patients who are eligible for participation to the study.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: Baseline up to data cut-off (Up to approximately 20 years)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Baseline up to data cut-off (Up to approximately 20 years)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHZS-lym-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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