Epstein-Barr Virus Status in Diffuse Large B Cell Lymphoma

Completed

• Conditions: Diffuse Large B-cell Lymphoma

• Registration Number: NCT02060435
• Lead Sponsor: Samsung Medical Center

Brief Summary

The investigators analyzed clinical outcome in DLBCL patients according to age group to define the impact of EBV status on the clinical outcome.

Detailed Description

Epstein-Barr virus (EBV) positive diffuse large B-cell lymphoma (DLBCL) has been recognized as a new provisional entity in the 2008 World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissue. This lymphoma is defined as EBV+ clonal B-cell proliferation in immunocompetent adults older than 50 years. To denote patient age in definition of this disease, age cutoff was defined as older than 50 years. However, this cutoff is clearly arbitrary without any scientific background. the knowledge on EBV+DLBCL in young adult is very scanty. This EBV+DLBCL in young adult can be the same disease entity or it can be a distinct disease form EBV+DLBCL of elderly.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-12
• Status Verified: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-12
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 571

Inclusion Criteria

• Pathologically confirmed de novo DLBCL, according to the World Health Organization (WHO) classification:

  • registered in Samsung Medical Center (SMC) Lymphoma Cohort Study I/II (ClinicalTrials.gov Identifier: NCT00822731, NCT01877109) or identified from Asan Medical Center (AMC) medical database:
  • adequate amount and quality of paraffin-embedded biopsy specimen or unstained slides for EBV-encoded RNA (EBER) in situ hybridization.

Exclusion Criteria

• Patients with unknown EBV status, primary central nervous system (CNS) lymphoma, post-transplant lymphoproliferative disorders (PTLDs), and HIV-positive DLBCL were excluded in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	Two years

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of