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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CSF analysis
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diffuse Large B-cell Lymphoma focused on measuring Diffuse large B cell lymphoma, central nervous system, prognosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center
  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

DLBCL with risk factor

Arm Description

Patients have any of risk factors for secondary CNS involvement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

survival
The survival outcome of patients will be monitored.

Full Information

First Posted
September 8, 2010
Last Updated
March 1, 2015
Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, National Cancer Center, Korea, Korea Cancer Center Hospital, Korea University
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1. Study Identification

Unique Protocol Identification Number
NCT01202448
Brief Title
Prospective Cohort Study With Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
Acronym
PROCESS
Official Title
Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, National Cancer Center, Korea, Korea Cancer Center Hospital, Korea University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
Diffuse large B cell lymphoma, central nervous system, prognosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLBCL with risk factor
Arm Type
Active Comparator
Arm Description
Patients have any of risk factors for secondary CNS involvement
Intervention Type
Procedure
Intervention Name(s)
CSF analysis
Other Intervention Name(s)
Brain MRI
Intervention Description
The cerebrospinal fluid will be evaluated via lumbar puncture.
Primary Outcome Measure Information:
Title
CNS relapse/involvement
Description
After enrollment, patients will be monitored to check the CNS relapse or involvement
Time Frame
Up to 2 years after participants are enrolled.
Secondary Outcome Measure Information:
Title
survival
Description
The survival outcome of patients will be monitored.
Time Frame
Up to 2 years after participants are enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed patients with diffuse large B cell lymphoma > 20 years life expectancy more than 6 months Written informed consent Exclusion Criteria: Refusal to informed consent Lymphomas other than diffuse large B cell lymphoma Primary CNS lymphoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheolwon Suh, MD, PhD
Organizational Affiliation
Consortium for Improving Survival of Lymphoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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