WHOLE EXOME SEQUENCING AND GENOTYPING
The IBD group in Leuven has been a full partner of the International IBD Genetics Consortium since its foundation in 1996. The aim of the international research on IBD genetics is to identify the underlying genes which contribute to the pathogenesis of the disease.
Whereas in the early years, linkage studies in IBD families were performed, this shifted rapidly to genome-wide association studies (GWAS), using a DNA-chip that can detect hundreds of thousands of small variations across the entire genome at the same time. By comparing these variations in IBD patients and non-IBD controls, these studies have so far identified more than 240 genetic risk variants and have advanced our understanding of what pathways are involved in triggering the disease. Today, the next step in genetic research on IBD involves the sequencing of all exomes, which carry the coding information for genes, so called whole-exome sequencing (WES). We will therefore perform WES and genotyping of our patients with IBD, as well as unaffected relatives and volunteers, to identify new genetic variants which may help further in developing tools to better diagnose, prognosticate or treat IBD.
The sequencing of the pseudonymised Leuven samples (the samples are coded with a unique number) will be performed at the Regeneron Genetics Center in New York (USA) and the results will be analyzed by our group.
UZ Leuven, under the oversight of Prof. Dr. Séverine Vermeire, is collaborating with Takeda Development Center Americas, Inc. (Takeda) in the study titled “Evaluation of the Exposure-Response Relationship of Vedolizumab in Inflammatory Bowel Disease: A Pooled Multi-Center Observational Cohort Analysis of Real World Clinical and Modeled Pharmacological Data” (ERELATE).
ERELATE is a retrospective, noninterventional study in which Takeda, the sponsor will collect and analyze patient health records from patients with a known diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) and who received treatment with vedolizumab (Entyvio). It is our intention to include your medical information in this study.
The purpose of this study is to better understand how the drug works over time in treating patients with your condition. This study is retrospective, meaning that the study will include only information that has been already collected in the past and stored in your medical record; no additional treatments or visits are necessary. Your data will help us understand the relationship between the dose of Entyvio™, and its impact on your medical condition.
Protecting the privacy of patients is an important obligation of sponsors who conduct clinical studies. In the context of this study, the data will be transferred in an encoded manner. The data is linked to your personal health information with code numbers, without your name and address, so that you cannot be identified from it. The code numbers will be kept secure by the study doctor at UZ Leuven. The UZ Leuven clinical trial team is responsible for the collection and encoding of the data and UZ Leuven remains the controller of the medical records. The Ethics Committee Research UZ / KU Leuven was informed and approved this Study.