Electronic Medical Records and Genomics (eMERGE) Phase III (eMERGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03394859|
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : May 28, 2020
|Condition or disease|
|Cardiac Disease Cancer Hypercholesterolemia Diabetes Kidney Diseases Neuromuscular Diseases|
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.
|Study Type :||Observational|
|Actual Enrollment :||25380 participants|
|Official Title:||Electronic Medical Records and Genomics (eMERGE) Phase III|
|Actual Study Start Date :||September 1, 2015|
|Actual Primary Completion Date :||April 1, 2020|
|Actual Study Completion Date :||April 1, 2020|
- Impact of return of clinically actionable results on patient treatment [ Time Frame: Six months post return of results ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394859
|Principal Investigator:||Teri Manolio, MD, PhD||National Human Genome Research Institute (NHGRI)|
|Principal Investigator:||John Harley, MD, PhD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Hakon Hakonarson, MD, PhD||Children's Hospital of Philadelphia|
|Principal Investigator:||Chunhua Weng, PhD||Columbia University|
|Principal Investigator:||Marc Williams, MD||Geisinger Clinic|
|Principal Investigator:||Elizabeth Karlson, MD||Harvard University|
|Principal Investigator:||Scott Hebbring, PhD||Marshfield Clinic|
|Principal Investigator:||Iftikhar Kullo, MD||Mayo Clinic|
|Principal Investigator:||Samuel Adunyah, PhD||Meharry Medical College|
|Principal Investigator:||Rex Chisholm, PhD||Northwestern University|
|Principal Investigator:||Gail Jarvik, MD, PhD||Kaiser Permanente Washington with the University of Washington and the Fred Hutchinson Cancer Research Center|
|Principal Investigator:||Dan Roden, MD||Vanderbilt University Medical Center|
|Principal Investigator:||Heidi Rehm, PhD||Partners Healthcare with Broad Institute|
|Principal Investigator:||Richard Gibbs, PhD||Baylor College Medicine|