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NCT01202448 Clinical Trial

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

Diffuse Large B-cell Lymphoma Clinical Trial

— PROCESS  

Official title:
Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01202448
Other study ID # 2010-04-091
Secondary ID
Status Completed
Phase N/A
First received September 8, 2010
Last updated March 1, 2015
Start date August 2010
Est. completion date February 2015

Study information
Verified date March 2015
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• CSF analysis
The cerebrospinal fluid will be evaluated via lumbar puncture.

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul

Sponsors (6)
Lead Sponsor Collaborator
Samsung Medical Center Asan Medical Center, Korea Cancer Center Hospital, Korea University, National Cancer Center, Korea, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary CNS relapse/involvement After enrollment, patients will be monitored to check the CNS relapse or involvement Up to 2 years after participants are enrolled. No
Secondary survival The survival outcome of patients will be monitored. Up to 2 years after participants are enrolled Yes
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