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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01606605
First received: May 22, 2012
Last updated: January 12, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Number of patients who relapse or progress after 1st line chemotherapy [ Time Frame: two years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01606605     History of Changes
Other Study ID Numbers: 2010-05-025
Study First Received: May 22, 2012
Last Updated: January 12, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013