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CompletedNCT02060435Updated Feb 12, 2014

Epstein-Barr Virus Status in Diffuse Large B Cell Lymphoma

An observational study in Diffuse Large B-cell Lymphoma, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 17 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-02-12.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
571
Ages
17 Years to 90 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Diffuse Large B-cell Lymphoma

Keywords

  • diffuse large B-cell lymphoma
  • Ebstein-Barr Virus
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In context

Epstein-Barr Virus Infections

159 studies on the registry are indexed under Epstein-Barr Virus Infections; 55 are open to participants now.

This study's enrollment of 571 is above the median of 140 across 43 observational studies indexed under Epstein-Barr Virus Infections.

Browse Epstein-Barr Virus Infections studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

(1) pathologically confirmed de novo DLBCL, according to the World Health Organization (WHO) classification: (ii) 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: (iii) adequate amount and quality of paraffin-embedded biopsy specimen or unstained slides for EBV-encoded RNA (EBER) in situ hybridization.

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
571 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • EBER+ AMC

    EBV+DLBCL patients in Asan Medical Center

    Other: EBER

  • EBER+ SMC

    EBV+DLBCL patients in Samsung Medical Center

    Other: EBER

  • EBER- SMC

    EBV-DLBCL patients in Samsung Medical Center

Interventions

  • OtherEBER

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

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What researchers measure

Primary outcomes

  1. overall survival

    Time frame: Two years

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Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
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References and documents

Publications

  • Hong JY, Yoon DH, Suh C, Huh J, Do IG, Sohn I, Jo J, Jung SH, Hong ME, Yoon H, Ko YH, Kim SJ, Kim WS. EBV-positive diffuse large B-cell lymphoma in young adults: is this a distinct disease entity? Ann Oncol. 2015 Mar;26(3):548-55. doi: 10.1093/annonc/mdu556. Epub 2014 Dec 4. PubMed 25475080 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02060435
Lead sponsor
Samsung Medical Center
Responsible party
Won Seog Kim (Professor, Samsung Medical Center) — Principal investigator
First posted
Feb 12, 2014
Start date
Jan 2013
Primary completion
Dec 2013
Completion
Feb 2014
Last update
Feb 12, 2014

Study contacts

Won Seog Kim, MD PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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