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

March 1, 2015 updated by: Kim, Seok Jin, Samsung Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Brain MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 2 years after participants are enrolled.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: Up to 2 years after participants are enrolled
The survival outcome of patients will be monitored.
Up to 2 years after participants are enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

National Cancer Center, Korea
Asan Medical Center
Korea University
Yonsei University
Korea Cancer Center Hospital

Investigators

  • Principal Investigator: Cheolwon Suh, MD, PhD, Consortium for Improving Survival of Lymphoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 15, 2010

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 1, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-04-091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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