Prospective Cohort Study With Central Nervous System Eval... | NCT01202448

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

NCT01202448

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Mar 3, 2015Estimated

Enrollment

600Actual

Phase

Not Applicable

Conditions

Diffuse Large B-cell Lymphoma

Interventions

CSF analysis

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Sep 8, 2010

First Submission Date that Met QC Criteria

Sep 14, 2010

First Posted Date

Sep 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2015

Last Update Posted Date

Mar 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kim, Seok Jin, Associate professor, Samsung Medical CenterPrincipal Investigator

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Name	Class
Asan Medical Center	OTHER
Yonsei University	OTHER
National Cancer Center, Korea	OTHER_GOV
Korea Cancer Center Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DLBCL with risk factor	Active Comparator	Patients have any of risk factors for secondary CNS involvement	Procedure: CSF analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CSF analysis	Procedure	The cerebrospinal fluid will be evaluated via lumbar puncture.	DLBCL with risk factor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cheolwon Suh, MD, PhD	Consortium for Improving Survival of Lymphoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135710	South Korea
Asan Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided