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

Samsung Medical Center

Status: Completed

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Procedure: CSF analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01202448

2010-04-091

Details and patient eligibility

About

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

Full 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

Enrollment: 600 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

DLBCL with risk factor

Active Comparator group

Description:

Patients have any of risk factors for secondary CNS involvement

Treatment:

Procedure: CSF analysis