Treatment Resistance Related With Gene Expression Profile... | NCT01606605

Studies
Treatment Resistance Related With Gene Expression Profile of Diffuse Large B-cell Lymphoma

NCT01606605

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jan 15, 2013Estimated

Enrollment

350Actual

Phase

Not provided

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Not provided

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

Jan 2013

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

Jan 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

May 22, 2012

First Submission Date that Met QC Criteria

May 23, 2012

First Posted Date

May 25, 2012Estimated

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

Jan 12, 2013

Last Update Posted Date

Jan 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The investigators perform a retrospective microarray gene expression profiling study of FFPE from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is correlated with clinical outcomes of diffuse large B-cell lymphoma.

Detailed Description

Whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay
- Diffuse large B-cell lymphoma patients
- Paraffin-embedded tissue
- End points: Progression-free survival, overall survival
- Statistics: Leave one-out method
Nano string assay for microRNA
- Diffuse large B-cell lymphoma patients
- Paraffin-embedded tissue
- End points: Progression-free survival, overall survival
- Statistics: Leave one-out method

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diffuse large B-cell lymphoma		Patients diagnosed and treated at the Samsung Medical Center

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who relapse or progress after 1st line chemotherapy		two years

Secondary Outcomes

Measure	Description	Time Frame
Number and type of genes and microRNA which are significantly related with relapse or progression (P < 0.05)		two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with diffuse large B-cell lymphoma
Patients with tissue blocks available for study
Patients with adequate medical records

Exclusion Criteria:

Patients diagnosed with other subtypes of lymphoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with diffuse large B-cell lymphoma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Won Seog Kim, MD, PhD	Samsung Medical Center Cancer Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Cancer Research Institute		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse
D008223	Lymphoma
D012008	Recurrence

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided