Electronic Medical Records and Genomics (eMERGE) Phase III (eMERGE)

May 27, 2020 updated by: Josh Peterson, Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

25380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Age: 1 day old
  • Vital status: Alive

Exclusion Criteria:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months post return of results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Iftikhar Kullo, MD, Mayo Clinic
  • 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eMERGEIII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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