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CompletedNCT01202448PROCESSUpdated Mar 3, 2015

Prospective Cohort Study With Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma

An interventional study of CSF analysis in Diffuse Large B-cell Lymphoma, sponsored by Samsung Medical Center. Completed at 2 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-03-03.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma.

Read the detailed description

We dichotomize patients according to the risk of CNS involvement. Then, we perform CNS evaluation in patients at risk of CNS involvement. We prospectively monitor whether CNS relapse or metastasis occurs in patients with diffuse large B-cell lymphoma

02

Conditions studied

  • Diffuse Large B-cell Lymphoma

Keywords

  • Diffuse large B cell lymphoma
  • central nervous system
  • prognosis
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 600 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma 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.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Newly diagnosed patients with diffuse large B cell lymphoma
  2. > 20 years
  3. life expectancy more than 6 months
  4. Written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Refusal to informed consent
  2. Lymphomas other than diffuse large B cell lymphoma
  3. Primary CNS lymphoma
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Active comparator
    DLBCL with risk factor

    Patients have any of risk factors for secondary CNS involvement

    Procedure: CSF analysis

Interventions

  • ProcedureCSF analysis

    The cerebrospinal fluid will be evaluated via lumbar puncture.

    Also known as: Brain MRI

06

What researchers measure

Primary outcomes

  1. CNS relapse/involvement

    After enrollment, patients will be monitored to check the CNS relapse or involvement

    Time frame: Up to 2 years after participants are enrolled.

Secondary outcomes

  1. survival

    The survival outcome of patients will be monitored.

    Time frame: Up to 2 years after participants are enrolled

07

Study locations

2 sites
  • Samsung Medical Center
    Seoul, 135710, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01202448
Lead sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, National Cancer Center, Korea, Korea Cancer Center Hospital, Korea University
Responsible party
Kim, Seok Jin (Associate professor, Samsung Medical Center) — Principal investigator
First posted
Sep 15, 2010
Start date
Aug 2010
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Mar 3, 2015

Study contacts

Cheolwon Suh, MD, PhD
principal investigator · Consortium for Improving Survival of Lymphoma

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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