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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01202448
Collaborator
Asan Medical Center (Other), Yonsei University (Other), National Cancer Center, Korea (Other), Korea Cancer Center Hospital (Other), Korea University (Other)
600
Enrollment
2
Locations
1
Arm
54
Duration (Months)
300
Patients Per Site
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: CSF analysis
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
600 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Brain MRI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CNS relapse/involvement [Up to 2 years after participants are enrolled.]

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

    Secondary Outcome Measures

    1. survival [Up to 2 years after participants are enrolled]

      The survival outcome of patients will be monitored.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    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:

    1. Refusal to informed consent

    2. Lymphomas other than diffuse large B cell lymphoma

    3. Primary CNS lymphoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135710
    2 Asan Medical Center Seoul Korea, Republic of

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kim, Seok Jin, Associate professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01202448
    Other Study ID Numbers:
    • 2010-04-091
    First Posted:
    Sep 15, 2010
    Last Update Posted:
    Mar 3, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Kim, Seok Jin, Associate professor, 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

    Study Results

    No Results Posted as of Mar 3, 2015