NCT01606605

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

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

January 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

May 22, 2012

Last Update Submit

January 12, 2013

Conditions

Diffuse Large B-cell Lymphoma

Keywords

LymphomaPrognosisRelapseGenemicroRNA

Outcome Measures

Primary Outcomes (1)

  • Number of patients who relapse or progress after 1st line chemotherapy

    two years

Secondary Outcomes (1)

  • Number and type of genes and microRNA which are significantly related with relapse or progression (P < 0.05)

    two years

Study Arms (1)

Diffuse large B-cell lymphoma

Patients diagnosed and treated at the Samsung Medical Center

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diffuse large B-cell lymphoma

You may qualify if:

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

You may not qualify if:

  • Patients diagnosed with other subtypes of lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Cancer Research Institute

Seoul, 135-710, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Parrafin-embedded tissue blocks

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphomaRecurrence

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Won Seog Kim, MD, PhD

    Samsung Medical Center Cancer Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 25, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

KR(1)