NCT01202448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

4.5 years

First QC Date

September 8, 2010

Last Update Submit

March 1, 2015

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Diffuse large B cell lymphomacentral nervous systemprognosis

Outcome Measures

Primary Outcomes (1)

  • CNS relapse/involvement

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

    Up to 2 years after participants are enrolled.

Secondary Outcomes (1)

  • survival

    Up to 2 years after participants are enrolled

Study Arms (1)

DLBCL with risk factor

ACTIVE COMPARATOR

Patients have any of risk factors for secondary CNS involvement

Procedure: CSF analysis

Interventions

CSF analysisPROCEDURE

The cerebrospinal fluid will be evaluated via lumbar puncture.

Also known as: Brain MRI
DLBCL with risk factor

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed patients with diffuse large B cell lymphoma
  • \> 20 years
  • life expectancy more than 6 months
  • Written informed consent

You may not qualify if:

  • Refusal to informed consent
  • Lymphomas other than diffuse large B cell lymphoma
  • Primary CNS lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, 135710, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cheolwon Suh, MD, PhD

    Consortium for Improving Survival of Lymphoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 15, 2010

Study Start

August 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

KR(2)