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

This study is currently recruiting participants.
Verified May 2012 by Samsung Medical Center

First Received on September 8, 2010.  
Last Updated on May 22, 2012  
History of Changes
This Clinical Trial Sponsored By: Samsung Medical Center
Collaborators: Asan Medical Center
Yonsei University
National Cancer Center, Korea
Korea Cancer Center Hospital
Korea University
Information provided by (Responsible Party): Kim, Seok Jin, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01202448
 

Purpose for Clinical Trial

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

Condition Study Intervention
Diffuse Large B-cell Lymphoma Procedure: CSF analysis

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures For Clinical Trial:

  • CNS relapse/involvement [ Time Frame: Up to 2 years after participants are enrolled. ] [ Designated as safety issue: No ]
    After enrollment, patients will be monitored to check the CNS relapse or involvement

Secondary Outcome Measures For Clinical Trial:

  • survival [ Time Frame: Up to 2 years after participants are enrolled ] [ Designated as safety issue: Yes ]
    The survival outcome of patients will be monitored.

Estimated Enrollment: 400
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Active Comparator: DLBCL with risk factor

Patients have any of risk factors for secondary CNS involvement
Procedure: CSF analysis

The cerebrospinal fluid will be evaluated via lumbar puncture.
Other Name: Brain MRI

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202448

Contacts
Contact: Seok Jin Kim, MD, PhD 82234101766 kstwoh@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135710
Contact: Seok Jin Kim, MD, PhD     82234101766        
Principal Investigator: Seok Jin Kim, MD, PhD            
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Cheolwon Suh, MD, PhD            
Principal Investigator: Cheolwon Suh, MD, PhD            
Sponsors and Collaborators
Samsung Medical Center
Asan Medical Center
Yonsei University
National Cancer Center, Korea
Korea Cancer Center Hospital
Korea University
Investigators
Principal Investigator: Cheolwon Suh, MD, PhD Consortium for Improving Survival of Lymphoma
  More Information

No publications provided

Responsible Party: Kim, Seok Jin, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01202448    
History of Changes
Other Study ID Numbers: 2010-04-091
Study First Received: September 8, 2010
Last Updated: May 22, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

Diffuse large B cell lymphoma
central nervous system
prognosis

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms

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