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

NCT ID: NCT01202448

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DLBCL with risk factor

Patients have any of risk factors for secondary CNS involvement

Group Type ACTIVE_COMPARATOR

CSF analysis

Intervention Type PROCEDURE

The cerebrospinal fluid will be evaluated via lumbar puncture.

Interventions

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CSF analysis

The cerebrospinal fluid will be evaluated via lumbar puncture.

Intervention Type PROCEDURE

Other Intervention Names

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Brain MRI

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Korea Cancer Center Hospital

OTHER

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kim, Seok Jin

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheolwon Suh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consortium for Improving Survival of Lymphoma

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2010-04-091

Identifier Type: -

Identifier Source: org_study_id

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