|Protocol: ||Genes in Diabetic Retinopathy Project
|Start Date: ||03/02/2012
|End Date: ||
|Clinical Trial ID: ||
|Public Dataset: ||
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A. Study Objective
· The goal of this project is to create a repository of at least 2000 participant's blood samples with extracted genetic materials and clinical phenotype information as a resource for the research co
B. Major Eligibility Criteria
· To be eligible for this project, a patient must currently be enrolled in an applicable DRCR.net study or previously been enrolled in an applicable DRCR.net study.
C. Blood Sample Collection
Blood samples will be collected from participants from DRCR.net protocols. Procedures for collecting blood samples are outlined in the Procedures Manual.
D. DNA Extraction
High-quality genomic DNA will be extracted from venous blood samples collected from DRCR.net study participants. The DNA will be made available for genome-wide or targeted SNP analyses, whole exome, whole genome sequencing, methylation analyses, or other analyses. At some sites, an additional blood sample may also be collected and used for serum extraction. With this serum, scientists might conduct proteomic or other analyses.
E. Sample Size
A minimum of 2000 participants
F. Duration of Follow-Up
N/A - One-time collection of a blood sample and DNA extraction is required for this project
G. Study Overview
A focus of the DRCR.net has been to conduct large-scale randomized comparative-effectiveness trials which therefore afford the opportunity to conduct well-powered pharmacogenetic analyses. Findings from genetic research may be adopted world-wide to assess risk of disease, prognosis, and response to interventions. It may also promote development of international research collaborations that would improve the lives of people around the world or accelerate fundamental discoveries.
H. Main Safety Outcomes