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Environmental Polymorphism Registry (EPR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00341237
Recruitment Status : Recruiting
First Posted : June 21, 2006
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Brief Summary:

The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to collect health, family history of disease, environmental exposures and lifestyle data on EPR participants. The EPR was established to collect and store DNA specimens from 20,000 participants and to serve as a resource for scientists investigating genotype-driven translational research of chronic health conditions. Under this protocol, question Health and Exposure Survey to EPR participants. The information used to better characterize the EPR population, thus making it more useful in answering research questions related to gene-environment interactions. Data from the survey will help researchers to advance clinical research by developing new ways of preventing, diagnosing, and treating common diseases such as cardiovascular disease, asthma, and diabetes.

During Phases I and II, the survey was administered to EPR participants using a modified version of the Dillman Total Design Method (TDM) (1) for surveys. This method requires following specific steps for survey administration that incorporate web-based, paper and phone administration. The rationale for using the TDM was to maximize participant response rates. As of August 2016, 9,000 EPR participants had responded during Phase I and II administration of the survey under protocol 12-E-0194. Efforts are ongoing to collect these data from additional EPR participants. During Phase III, under protocol 04-E-0053, the survey will be distributed to new EPR participants (i.e., those who were not enrolled in the EPR at the time of the Phase I and II survey administrations under protocol 12-E-0194) for self-administration at the time of enrollment and to existing EPR participants who have not yet completed the survey.

Investigators may select and contact participants for follow-up studies based upon health, exposure, or disease status information; this includes responses to the EPR Health and Exposure Survey. Participation in follow-up studies is completely voluntary. Participants can decide at the time they are contacted if they would like to enroll in the follow-up study. Their decision whether or not to participate in a follow-up study will not affect their participation in the EPR.


Condition or disease
Diabetes Heart Disease Asthma

Detailed Description:

The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to collect health, family history of disease, environmental exposures and lifestyle data on EPR participants. The EPR was established to collect and store DNA specimens from 20,000 participants and to serve as a resource for scientists investigating genotype-driven translational research of chronic health conditions. Under this protocol, question Health and Exposure Survey to EPR participants. The information used to better characterize the EPR population, thus making it more useful in answering research questions related to gene-environment interactions. Data from the survey will help researchers to advance clinical research by developing new ways of preventing, diagnosing, and treating common diseases such as cardiovascular disease, asthma, and diabetes.

During Phases I and II, the survey was administered to EPR participants using a modified version of the Dillman Total Design Method (TDM) (1) for surveys. This method requires following specific steps for survey administration that incorporate web-based, paper and phone administration. The rationale for using the TDM was to maximize participant response rates. As of August 2016, 9,000 EPR participants had responded during Phase I and II administration of the survey under protocol 12-E-0194. Efforts are ongoing to collect these data from additional EPR participants. During Phase III, under protocol 04-E-0053, the survey will be distributed to new EPR participants (i.e., those who were not enrolled in the EPR at the time of the Phase I and II survey administrations under protocol 12-E-0194) for self-administration at the time of enrollment and to existing EPR participants who have not yet completed the survey.

Investigators may select and contact participants for follow-up studies based upon health, exposure, or disease status information; this includes responses to the EPR Health and Exposure Survey. Participation in follow-up studies is completely voluntary. Participants can decide at the time they are contacted if they would like to enroll in the follow-up study. Their decision whether or not to participate in a follow-up study will not affect their participation in the EPR.

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Environmental Polymorphism Registry (EPR)
Actual Study Start Date : April 1, 2005

Group/Cohort
polymorphisms
Specimens are available to investigators in coded form to anonymously screen for the presence of single-nucleotide polymorphisms (SNPs) and other mutations in DNA.



Primary Outcome Measures :
  1. Disease [ Time Frame: end of study ]
    Genetic changes and disease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 130 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample from the general population.
Criteria
  • INCLUSION AND EXCLUSION CRITERIA:
  • Adults (greater than or equal to 18 years of age) or minors (ages 8-17 years old) are eligible to enroll in the Environmental Polymorphisms Registry.
  • Participants must be able to understand and provide written informed consent (adult participants or parent/ guardian of minors) and assent (minors) to participate.

There are no other inclusion or exclusion criteria.


Information from the National Library of Medicine

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): NCT00341237


Contacts
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Contact: Jamie R Glover (800) 860-3804 info@eprdna.niehs.nih.gov
Contact: Shepherd H Schurman, M.D. (984) 287-4411 schurmansh@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Rita Volochayev, M.D.    301-451-6266    rita.volochayev@nih.gov   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Paul Watkins, M.D.    Not Listed    pbwatkins@med.unc.edu   
RENCI (Renaissance Computing Institute) Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Ashok Krishnamurthy, Ph.D.    919-445-9643    ashok@renci.org   
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Robert Tighe, M.D.    Not Listed    robert.tighe@duke.edu   
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States
Contact: Nicole Edwards    984-287-4416    nicole.edwards@nih.gov   
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Shepherd H Schurman, M.D. National Institute of Environmental Health Sciences (NIEHS)
Additional Information:
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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00341237    
Other Study ID Numbers: 040053
04-E-0053
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 21, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Genotype
Phenotype
Environmental Factor
Single Nucleotide Polymorphism
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases