Genetic DiseaseeMERGENCT05277116
The Electronic Medical Records and GEnomics (eMERGE) Network Genomic Risk Assessment
A study testing Genome Informed Risk Assessment (GIRA) report in people with Genetic Disease, run by Vanderbilt University Medical Center at 12 sites in United States.
Trial summary
The eMERGE Network embraces the opportunity to use new methods in genomic medicine, information science, and research participant engagement to identify people at very high risk for specific diseases and recommend individualized approaches to prevention and care. Read more about this study
- Who is it for?
- Ages 3 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Disease
- What is being tested?
- Genome Informed Risk Assessment (GIRA) report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,877 participants
- Where
- 12 sitesUnited States
- Study dates
- 16 Feb 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults 18-75
- Children 3 to < 18
- Able to read or understand English or Spanish
- Able to provide a healthcare provider or clinician to receive results
- Willing to accept GIRA report
Who cannot join
- Inability to provide consent
- Transplant (solid organ or bone marrow) or transfusion within 8 weeks
- Research staff and investigators in eMERGE
- Not a patient at parent institution
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Mount Sinai
New York, New York, 10029
Columbia University
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98195
Mountain Park Health Center
Tempe, Arizona, 85012
About this study
The eMERGE Network embraces the opportunity to use new methods in genomic medicine, information science, and research participant engagement to identify people at very high risk for specific diseases and recommend individualized approaches to prevention and care. The investigators will conduct a prospective study, with diverse and underserved participants, across ten eMERGE study sites to evaluate clinical implementation of a Genome Informed Risk Assessment (GIRA) tool that combines genetic, family history, and clinical risk information from participants.
Read the detailed description
The purpose of the study is to determine if providing a Genome Informed Risk Assessment (GIRA) will impact clinical actions taken by providers and patients to manage disease risk and the propensity of participants to develop a disease reported in the GIRA. New tools in Genomic Medicine - polygenic risk scores, monogenic genetic screening tests, platforms to capture family history, and advanced electronic phenotyping - offer the prospect of early identification of people at especially high risk of common diseases. The investigators developed methods to generate integrated genomic risk assessments for ten conditions; a plan to engage, recruit, and retain ~25,000 subjects to receive these assessments; and methods to study outcomes in those designated high risk and those designated non-high risk. By enhancing understanding of new methods to create and deliver integrated genomic risk assessments, this project will enable prevention and early treatment of people at high risk for common diseases.
- Conditions
- Genetic Disease
- Being tested
- Genome Informed Risk Assessment (GIRA) report
- Keywords
- Genomic Risk, Genomic Medicine, GIRA, Genome Informed Risk Assessment, Risk Report
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genome Informed Risk Assessment (GIRA) reportOther
A Genome Informed Risk Assessment (GIRA) report that combines genetic (monogenic risks and polygenic risk scores), family history, and clinical risk information from participants.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving a Genome Informed Risk Assessment (GIRA) | Experimental | All participants and their health care providers will receive a Genome Informed Risk Assessment (GIRA) report. Receives: Other: Genome Informed Risk Assessment (GIRA) report |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of new health care actions after return of the genome-informed risk assessment
Number of new health care actions will be measured by electronic health record data and participant-reported outcomes through a REDCap survey. Pre-specified actions will include a condition-specific composite of new encounters, clinical orders, or specialty referrals for clinical evaluation associated with the condition(s), placed by a provider within 6 months of result disclosure.
Measured: Baseline to 6 months post return of results to participant
Secondary outcomes (2)
Number of newly diagnosed conditions after return of the genome-informed risk assessment
Number of newly diagnosed conditions included in the eMERGE study will be measured by data from participant electronic health records
Measured: 6 months and 12 months post return of results to participant
Number of risk-reducing interventions after return of the genome-informed risk assessment
Number of risk-reducing interventions will be measured by REDCap survey along with data from participant electronic health records
Measured: 6 months and 12 months post return of results to participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start16 Feb 2022
- Primary completion30 Apr 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for Genetic DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive a genome informed risk assessment (GIRA) report. Participants designated as high risk based on their genomic risks will be compared to those without such risks for each condition.
- Masking
- None (open label)
- Enrolment
- 26,877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josh Peterson, Vanderbilt University Medical Center
- Investigators
- Josh Peterson, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277116
- Sponsor's protocol ID
- 211043
- Acronym
- eMERGE
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roden DM, Pulley JM, Basford MA, Bernard GR, Clayton EW, Balser JR, Masys DR. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin Pharmacol Ther. 2008 Sep;84(3):362-9. doi: 10.1038/clpt.2008.89. Epub 2008 May 21.
PubMed 18500243Pulley J, Clayton E, Bernard GR, Roden DM, Masys DR. Principles of human subjects protections applied in an opt-out, de-identified biobank. Clin Transl Sci. 2010 Feb;3(1):42-8. doi: 10.1111/j.1752-8062.2010.00175.x.
PubMed 20443953Bowton E, Field JR, Wang S, Schildcrout JS, Van Driest SL, Delaney JT, Cowan J, Weeke P, Mosley JD, Wells QS, Karnes JH, Shaffer C, Peterson JF, Denny JC, Roden DM, Pulley JM. Biobanks and electronic medical records: enabling cost-effective research. Sci Transl Med. 2014 Apr 30;6(234):234cm3. doi: 10.1126/scitranslmed.3008604.
PubMed 24786321Pulley JM, Brace MM, Bernard GR, Masys DR. Attitudes and perceptions of patients towards methods of establishing a DNA biobank. Cell Tissue Bank. 2008 Mar;9(1):55-65. doi: 10.1007/s10561-007-9051-2. Epub 2007 Oct 25.
PubMed 17960495Rosenbloom ST, Madison JL, Brothers KB, Bowton EA, Clayton EW, Malin BA, Roden DM, Pulley J. Ethical and practical challenges to studying patients who opt out of large-scale biorepository research. J Am Med Inform Assoc. 2013 Dec;20(e2):e221-5. doi: 10.1136/amiajnl-2013-001937. Epub 2013 Jul 25.
PubMed 23886923Bowton EA, Collier SP, Wang X, Sutcliffe CB, Van Driest SL, Couch LJ, Herrera M, Jerome RN, Slebos RJ, Alborn WE, Liebler DC, McNaughton CD, Mernaugh RL, Wells QS, Brown NJ, Roden DM, Pulley JM. Phenotype-Driven Plasma Biobanking Strategies and Methods. J Pers Med. 2015 May 14;5(2):140-52. doi: 10.3390/jpm5020140.
PubMed 26110578Brothers KB, Westbrook MJ, Wright MF, Myers JA, Morrison DR, Madison JL, Pulley JM, Clayton EW. Patient awareness and approval for an opt-out genomic biorepository. Per Med. 2013 Jun;10(4):10.2217/pme.13.34. doi: 10.2217/pme.13.34.
PubMed 24416062Pulley JM, Denny JC, Peterson JF, Bernard GR, Vnencak-Jones CL, Ramirez AH, Delaney JT, Bowton E, Brothers K, Johnson K, Crawford DC, Schildcrout J, Masys DR, Dilks HH, Wilke RA, Clayton EW, Shultz E, Laposata M, McPherson J, Jirjis JN, Roden DM. Operational implementation of prospective genotyping for personalized medicine: the design of the Vanderbilt PREDICT project. Clin Pharmacol Ther. 2012 Jul;92(1):87-95. doi: 10.1038/clpt.2011.371. Epub 2012 May 16.
PubMed 22588608Delaney JT, Ramirez AH, Bowton E, Pulley JM, Basford MA, Schildcrout JS, Shi Y, Zink R, Oetjens M, Xu H, Cleator JH, Jahangir E, Ritchie MD, Masys DR, Roden DM, Crawford DC, Denny JC. Predicting clopidogrel response using DNA samples linked to an electronic health record. Clin Pharmacol Ther. 2012 Feb;91(2):257-63. doi: 10.1038/clpt.2011.221. Epub 2011 Dec 21.
PubMed 22190063Karnes JH, Van Driest S, Bowton EA, Weeke PE, Mosley JD, Peterson JF, Denny JC, Roden DM. Using systems approaches to address challenges for clinical implementation of pharmacogenomics. Wiley Interdiscip Rev Syst Biol Med. 2014 Mar-Apr;6(2):125-35. doi: 10.1002/wsbm.1255. Epub 2013 Dec 6.
PubMed 24319008Peterson JF, Bowton E, Field JR, Beller M, Mitchell J, Schildcrout J, Gregg W, Johnson K, Jirjis JN, Roden DM, Pulley JM, Denny JC. Electronic health record design and implementation for pharmacogenomics: a local perspective. Genet Med. 2013 Oct;15(10):833-41. doi: 10.1038/gim.2013.109. Epub 2013 Sep 5.
PubMed 24009000Schildcrout JS, Denny JC, Bowton E, Gregg W, Pulley JM, Basford MA, Cowan JD, Xu H, Ramirez AH, Crawford DC, Ritchie MD, Peterson JF, Masys DR, Wilke RA, Roden DM. Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. Clin Pharmacol Ther. 2012 Aug;92(2):235-42. doi: 10.1038/clpt.2012.66. Epub 2012 Jun 27.
PubMed 22739144Van Driest SL, Shi Y, Bowton EA, Schildcrout JS, Peterson JF, Pulley J, Denny JC, Roden DM. Clinically actionable genotypes among 10,000 patients with preemptive pharmacogenomic testing. Clin Pharmacol Ther. 2014 Apr;95(4):423-31. doi: 10.1038/clpt.2013.229. Epub 2013 Nov 19.
PubMed 24253661Harris PA, Scott KW, Lebo L, Hassan N, Lightner C, Pulley J. ResearchMatch: a national registry to recruit volunteers for clinical research. Acad Med. 2012 Jan;87(1):66-73. doi: 10.1097/ACM.0b013e31823ab7d2.
PubMed 22104055Danciu I, Cowan JD, Basford M, Wang X, Saip A, Osgood S, Shirey-Rice J, Kirby J, Harris PA. Secondary use of clinical data: the Vanderbilt approach. J Biomed Inform. 2014 Dec;52:28-35. doi: 10.1016/j.jbi.2014.02.003. Epub 2014 Feb 14.
PubMed 24534443
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Electronic Medical Records and GEnomics (eMERGE) Network Genomic Risk Assessment
- ClinicalTrials.gov ID
- NCT05277116
- Acronym / sponsor ID
- eMERGE / 211043
- Conditions
- Genetic Disease
- Keywords
- Genomic Risk, Genomic Medicine, GIRA, Genome Informed Risk Assessment, Risk Report
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26,877 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The eMERGE Network embraces the opportunity to use new methods in genomic medicine, information science, and research participant engagement to identify people at very high risk for specific diseases and recommend individualized approaches to prevention and care. The investigators will conduct a prospective study, with diverse and underserved participants, across ten eMERGE study sites to evaluate clinical implementation of a Genome Informed Risk Assessment (GIRA) tool that combines genetic, family history, and clinical risk information from participants.
Detailed description
The purpose of the study is to determine if providing a Genome Informed Risk Assessment (GIRA) will impact clinical actions taken by providers and patients to manage disease risk and the propensity of participants to develop a disease reported in the GIRA. New tools in Genomic Medicine - polygenic risk scores, monogenic genetic screening tests, platforms to capture family history, and advanced electronic phenotyping - offer the prospect of early identification of people at especially high risk of common diseases. The investigators developed methods to generate integrated genomic risk assessments for ten conditions; a plan to engage, recruit, and retain ~25,000 subjects to receive these assessments; and methods to study outcomes in those designated high risk and those designated non-high risk. By enhancing understanding of new methods to create and deliver integrated genomic risk assessments, this project will enable prevention and early treatment of people at high risk for common diseases.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive a genome informed risk assessment (GIRA) report. Participants designated as high risk based on their genomic risks will be compared to those without such risks for each condition.
| Arm | Type | Receives |
|---|---|---|
| Participants receiving a Genome Informed Risk Assessment (GIRA) | Experimental | Other: Genome Informed Risk Assessment (GIRA) reportAll participants and their health care providers will receive a Genome Informed Risk Assessment (GIRA) report. |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18-75
- Children 3 to < 18
- Able to read or understand English or Spanish
- Able to provide a healthcare provider or clinician to receive results
- Willing to accept GIRA report
Key exclusion criteria (4 listed)
- Inability to provide consent
- Transplant (solid organ or bone marrow) or transfusion within 8 weeks
- Research staff and investigators in eMERGE
- Not a patient at parent institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genome Informed Risk Assessment (GIRA) reportA Genome Informed Risk Assessment (GIRA) report that combines genetic (monogenic risks and polygenic risk scores), family history, and clinical risk information from participants. | Other | Participants receiving a Genome Informed Risk Assessment (GIRA) |
Primary outcome
The number of new health care actions after return of the genome-informed risk assessment
Time frame: Baseline to 6 months post return of results to participant
Number of new health care actions will be measured by electronic health record data and participant-reported outcomes through a REDCap survey. Pre-specified actions will include a condition-specific composite of new encounters, clinical orders, or specialty referrals for clinical evaluation associated with the condition(s), placed by a provider within 6 months of result disclosure.
2 secondary outcomes
Number of newly diagnosed conditions after return of the genome-informed risk assessment
Time frame: 6 months and 12 months post return of results to participant
Number of risk-reducing interventions after return of the genome-informed risk assessment
Time frame: 6 months and 12 months post return of results to participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 18500243Roden DM, Pulley JM, Basford MA, Bernard GR, Clayton EW, Balser JR, Masys DR. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin Pharmacol Ther. 2008 Sep;84(3):362-9. doi: 10.1038/clpt.2008.89. Epub 2008 May 21.
- Background: PubMed 20443953Pulley J, Clayton E, Bernard GR, Roden DM, Masys DR. Principles of human subjects protections applied in an opt-out, de-identified biobank. Clin Transl Sci. 2010 Feb;3(1):42-8. doi: 10.1111/j.1752-8062.2010.00175.x.
- Background: PubMed 24786321Bowton E, Field JR, Wang S, Schildcrout JS, Van Driest SL, Delaney JT, Cowan J, Weeke P, Mosley JD, Wells QS, Karnes JH, Shaffer C, Peterson JF, Denny JC, Roden DM, Pulley JM. Biobanks and electronic medical records: enabling cost-effective research. Sci Transl Med. 2014 Apr 30;6(234):234cm3. doi: 10.1126/scitranslmed.3008604.
- Background: PubMed 17960495Pulley JM, Brace MM, Bernard GR, Masys DR. Attitudes and perceptions of patients towards methods of establishing a DNA biobank. Cell Tissue Bank. 2008 Mar;9(1):55-65. doi: 10.1007/s10561-007-9051-2. Epub 2007 Oct 25.
- Background: PubMed 23886923Rosenbloom ST, Madison JL, Brothers KB, Bowton EA, Clayton EW, Malin BA, Roden DM, Pulley J. Ethical and practical challenges to studying patients who opt out of large-scale biorepository research. J Am Med Inform Assoc. 2013 Dec;20(e2):e221-5. doi: 10.1136/amiajnl-2013-001937. Epub 2013 Jul 25.
- Background: PubMed 26110578Bowton EA, Collier SP, Wang X, Sutcliffe CB, Van Driest SL, Couch LJ, Herrera M, Jerome RN, Slebos RJ, Alborn WE, Liebler DC, McNaughton CD, Mernaugh RL, Wells QS, Brown NJ, Roden DM, Pulley JM. Phenotype-Driven Plasma Biobanking Strategies and Methods. J Pers Med. 2015 May 14;5(2):140-52. doi: 10.3390/jpm5020140.
- Background: PubMed 24416062Brothers KB, Westbrook MJ, Wright MF, Myers JA, Morrison DR, Madison JL, Pulley JM, Clayton EW. Patient awareness and approval for an opt-out genomic biorepository. Per Med. 2013 Jun;10(4):10.2217/pme.13.34. doi: 10.2217/pme.13.34.
- Background: PubMed 22588608Pulley JM, Denny JC, Peterson JF, Bernard GR, Vnencak-Jones CL, Ramirez AH, Delaney JT, Bowton E, Brothers K, Johnson K, Crawford DC, Schildcrout J, Masys DR, Dilks HH, Wilke RA, Clayton EW, Shultz E, Laposata M, McPherson J, Jirjis JN, Roden DM. Operational implementation of prospective genotyping for personalized medicine: the design of the Vanderbilt PREDICT project. Clin Pharmacol Ther. 2012 Jul;92(1):87-95. doi: 10.1038/clpt.2011.371. Epub 2012 May 16.
- Background: PubMed 22190063Delaney JT, Ramirez AH, Bowton E, Pulley JM, Basford MA, Schildcrout JS, Shi Y, Zink R, Oetjens M, Xu H, Cleator JH, Jahangir E, Ritchie MD, Masys DR, Roden DM, Crawford DC, Denny JC. Predicting clopidogrel response using DNA samples linked to an electronic health record. Clin Pharmacol Ther. 2012 Feb;91(2):257-63. doi: 10.1038/clpt.2011.221. Epub 2011 Dec 21.
- Background: PubMed 24319008Karnes JH, Van Driest S, Bowton EA, Weeke PE, Mosley JD, Peterson JF, Denny JC, Roden DM. Using systems approaches to address challenges for clinical implementation of pharmacogenomics. Wiley Interdiscip Rev Syst Biol Med. 2014 Mar-Apr;6(2):125-35. doi: 10.1002/wsbm.1255. Epub 2013 Dec 6.
- Background: PubMed 24009000Peterson JF, Bowton E, Field JR, Beller M, Mitchell J, Schildcrout J, Gregg W, Johnson K, Jirjis JN, Roden DM, Pulley JM, Denny JC. Electronic health record design and implementation for pharmacogenomics: a local perspective. Genet Med. 2013 Oct;15(10):833-41. doi: 10.1038/gim.2013.109. Epub 2013 Sep 5.
- Background: PubMed 22739144Schildcrout JS, Denny JC, Bowton E, Gregg W, Pulley JM, Basford MA, Cowan JD, Xu H, Ramirez AH, Crawford DC, Ritchie MD, Peterson JF, Masys DR, Wilke RA, Roden DM. Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. Clin Pharmacol Ther. 2012 Aug;92(2):235-42. doi: 10.1038/clpt.2012.66. Epub 2012 Jun 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Peterson, MD, MPH principal investigator
Vanderbilt University Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genome Informed Risk Assessment (GIRA) report in people with Genetic Disease, run by Vanderbilt University Medical Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of new health care actions after return of the genome-informed risk assessment (time frame: Baseline to 6 months post return of results to participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277116, which also lists 66 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.