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

January 12, 2013 updated by: Won Seog Kim, Samsung Medical Center

Retrospective Analysis of Diffuse Large B-cell Lymphoma: Identification of Factors Associated With Treatment Resistance Via Gene Expression Profile

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.

Study Overview

Status

Completed

Conditions

Detailed Description

  1. 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

  2. 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

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with diffuse large B-cell lymphoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Diffuse large B-cell lymphoma
Patients diagnosed and treated at the Samsung Medical Center

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Won Seog Kim, MD, PhD, Samsung Medical Center Cancer Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 12, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-05-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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