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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606605
First Posted: May 25, 2012
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
  Purpose
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.

Condition
Diffuse Large B-cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Diffuse Large B-cell Lymphoma: Identification of Factors Associated With Treatment Resistance Via Gene Expression Profile

Resource links provided by NLM:


Further study details as provided by Won Seog Kim, Samsung Medical Center:

Primary Outcome Measures:
  • Number of patients who relapse or progress after 1st line chemotherapy [ Time Frame: two years ]

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

Biospecimen Retention:   Samples With DNA
Parrafin-embedded tissue blocks

Enrollment: 350
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diffuse large B-cell lymphoma
Patients diagnosed and treated at the Samsung Medical Center

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diffuse large B-cell lymphoma
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606605


Locations
Korea, Republic of
Samsung Cancer Research Institute
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won Seog Kim, MD, PhD Samsung Medical Center Cancer Research Institute
  More Information

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01606605     History of Changes
Other Study ID Numbers: 2010-05-025
First Submitted: May 22, 2012
First Posted: May 25, 2012
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Won Seog Kim, Samsung Medical Center:
Lymphoma
Prognosis
Relapse
Gene
microRNA

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin