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Completed

NCT Number: NCT01202448

Prospective Cohort Study With 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSF analysis

Procedure

The cerebrospinal fluid will be evaluated via lumbar puncture.

Other names: Brain MRI

Primary outcomes

  1. 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

Secondary outcomes

  1. survival

    Time frame: Up to 2 years after participants are enrolled

    The survival outcome of patients will be monitored.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PROCESS

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2010
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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