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Completed

NCT Number: NCT02060435

Epstein-Barr Virus Status in Diffuse Large B Cell Lymphoma

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

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

17 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EBER

Other

EBV RNA was detected by an in situ hybridization (ISH) technique using the EBV ISH kit (Leica Microsystems, Bannockburn, IL, USA).

Primary outcomes

  1. overall survival

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Impact of the Epstein-Barr Virus Status on Clinical Outcome in Diffuse Large B Cell Lymphoma

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 12, 2014
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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