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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
Sponsor:
Information provided by (Responsible Party):
Josh Peterson, Vanderbilt University Medical Center

Tracking Information
First Submitted Date December 18, 2017
First Posted Date January 9, 2018
Last Update Posted Date May 28, 2020
Actual Study Start Date September 1, 2015
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electronic Medical Records and Genomics (eMERGE) Phase III
Official Title Electronic Medical Records and Genomics (eMERGE) Phase III
Brief Summary 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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples are drawn from patients after consent in a CLIA certified manner. These samples are processed, DNA is extracted and sent to one of two sequencing centers (Baylor College of Medicine or Partners Healthcare with Broad Institute). DNA is then sequenced and clinical reports along with sequencing results returned to sites.
Sampling Method Probability Sample
Study Population 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.
Condition
  • Cardiac Disease
  • Cancer
  • Hypercholesterolemia
  • Diabetes
  • Kidney Diseases
  • Neuromuscular Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 27, 2020)
25380
Original Estimated Enrollment
 (submitted: January 8, 2018)
25000
Actual Study Completion Date April 1, 2020
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age: 1 day old
  • Vital status: Alive

Exclusion Criteria:

-None

Sex/Gender
Sexes Eligible for Study: All
Ages up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03394859
Other Study ID Numbers eMERGEIII
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Josh Peterson, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Not Provided
Investigators
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
PRS Account Vanderbilt University Medical Center
Verification Date May 2020