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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Samsung Medical Center
Sponsor:
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
First received: September 8, 2010
Last updated: January 12, 2013
Last verified: January 2013
  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: 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 Samsung Medical Center:

Primary Outcome Measures:
  • 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:
  • 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
Primary Completion Date: October 2012 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Cheolwon Suh, MD, PhD         
Principal Investigator: Cheolwon Suh, MD, PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135710
Contact: Seok Jin Kim, MD, PhD    82234101766      
Principal Investigator: Seok Jin Kim, 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: January 12, 2013
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014