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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202448
First Posted: September 15, 2010
Last Update Posted: March 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kim, Seok Jin, Samsung Medical Center:

Primary Outcome Measures:
  • CNS relapse/involvement [ Time Frame: Up to 2 years after participants are enrolled. ]
    After enrollment, patients will be monitored to check the CNS relapse or involvement


Secondary Outcome Measures:
  • survival [ Time Frame: Up to 2 years after participants are enrolled ]
    The survival outcome of patients will be monitored.


Enrollment: 600
Study Start Date: August 2010
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202448


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135710
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
  More Information

Responsible Party: Kim, Seok Jin, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01202448     History of Changes
Other Study ID Numbers: 2010-04-091
First Submitted: September 8, 2010
First Posted: September 15, 2010
Last Update Posted: March 3, 2015
Last Verified: March 2015

Keywords provided by Kim, Seok Jin, 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
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin