An observational study in Cardiac Disease, Cancer and Hypercholesterolemia, sponsored by Vanderbilt University Medical Center. Completed. Open to participants aged 1 Day to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-28.
Sponsored by Vanderbilt University Medical Center · Observational
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The Electronic Medical Records and Genomics (eMERGE) Network is in its third phase and during this time is enrolling and sequencing 25,000 individuals on a custom sequencing panel of clinically relevant, actionable genes. The genetic results will be returned to participants and outcomes tracked through the electronic health records.
The Electronic Medical Records and Genomics (eMERGE) Network is a National Human Genome Research Institute (NHGRI)-funded consortium tasked with developing methods and best practices for utilization of the electronic medical record (EMR) as a tool for genomic research. Phase III is focused on returning actionable gene variants to patients and measuring clinical outcomes. Ultimately, eMERGE hopes its efforts will result in improvements in health care, through safer and more effective prescription methodology, augmentation of primary and secondary prevention strategies, and enhanced understanding of the biology of disease.
eMERGE is composed of 10 clinical sites [ Childrens Hospital of Pennsylvania (CHOP); Cincinnati Children's Medical Center (CCHMC); Columbia University; Geisinger; Kaiser Permanente Washington with Washington University and the Fred Hutchinson Cancer Research Center; Harvard University; Mayo Clinic; Meharry Medical College; Northwestern University; Vanderbilt University Medical center (VUMC)], one non clinical site: Marshfield Clinic, two sequencing centers [Baylor college of Medicine; Partners Healthcare with Broad Institute], a Coordinating Center (VUMC), and the NHGRI. More information on the eMERGE Network can be found at www.gwas.org.
Each sites' research study is tailored to their specific interests. An eMERGE specific sequencing panel was designed and ran on participants covering 109 genes and 1551 Single Nucleotide Variants (SNVs), of which 68 genes and 14 SNVs are clinically actionable and are being returned to patients.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's enrollment of 25,380 is above the median of 350 across 592 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Vanderbilt University Medical Center is the lead sponsor of 835 studies on the registry; 155 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 92 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Approximately 2500 to 3000 participants are enrolled at each site. Two sites (CCHMC and CHOP) are primarily enrolling pediatric patients while the rest focus on adult populations. Each site has unique specific aims and due to this cohorts differ slightly at each site. After sequencing is complete the data from all sites will be pooled into one large data set to allow for cross site analysis.
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Exclusion Criteria:
-None
Impact of return of clinically actionable results on patient treatment
The network will abstract data from patient electronic health records (EHR) six months after clinically actionable results have been returned to the patients and providers. The Network will determine changes in medication or treatments after return of the sequencing results. Outcome measures on patients receiving both positive and negative results will be analyzed.
Time frame: Six months post return of results
No study locations are listed for this record.
Plan to share: No
Ran from Sep 2015 to primary completion in Apr 2020, 55 months.
Of 184 non-industry observational studies under Heart Diseases, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's 55 months is above that.
Counting every sponsor, half of 238 studies reached it within 45 months; a quarter within 18 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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