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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 22, 2014