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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01606605
Other study ID # 2010-05-025
Secondary ID
Status Completed
Phase N/A
First received May 22, 2012
Last updated January 12, 2013
Start date January 2011
Est. completion date December 2012

Study information

Verified date January 2013
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 90 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
Korea, Republic of Samsung Cancer Research Institute Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who relapse or progress after 1st line chemotherapy two years No
Secondary Number and type of genes and microRNA which are significantly related with relapse or progression (P < 0.05) two years No
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