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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01202448
Acronym
PROCESS
Enrollment
600
Registered
2010-09-15
Start date
2010-08-31
Completion date
2015-02-28
Last updated
2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Diffuse large B cell lymphoma, central nervous system, prognosis

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

Interventions

PROCEDURECSF analysis

The cerebrospinal fluid will be evaluated via lumbar puncture.

Sponsors

Asan Medical Center
CollaboratorOTHER
Yonsei University
CollaboratorOTHER
National Cancer Center, Korea
CollaboratorOTHER_GOV
Korea Cancer Center Hospital
CollaboratorOTHER
Korea University
CollaboratorOTHER
Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CNS relapse/involvementUp to 2 years after participants are enrolled.After enrollment, patients will be monitored to check the CNS relapse or involvement

Secondary

MeasureTime frameDescription
survivalUp to 2 years after participants are enrolledThe survival outcome of patients will be monitored.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026