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Protocol Details

Personalized Environment and Genes Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

04-E-0053

Sponsoring Institute

National Institute of Environmental Health Sciences (NIEHS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 130 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Genotype;
Phenotype;
Environmental Factor;
Single Nucleotide Polymorphism;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Diabetes;
Heart Disease;
Asthma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Environmental Health Sciences

The Personalized Environment and Genes Study (PEGS) Health and Exposure Survey is designed to collect health, family history of disease, environmental exposures and lifestyle data on PEGS participants. PEGS 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 PEGS participants. The information used to better characterize the PEGS 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 PEGS 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 PEGS 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 PEGS participants. During Phase III, under protocol 04-E-0053, the survey will be distributed to new PEGS participants (i.e., those who were not enrolled in PEGS 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 PEGS 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 PEGS 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 PEGS.

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Eligibility

INCLUSION AND EXCLUSION CRITERIA:

-Non-Pregnant 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.

-Women who self-report that they are currently pregnant will be excluded from eligibility. A pregnancy test will only be done if the PI feels it is indicated. As of 1/27/2022, minors (under the age of 18) will not be enrolled in PEGS.

There are no other inclusion or exclusion criteria.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Janet E. Hall, M.D.
National Institute of Environmental Health Sciences (NIEHS)
RTP 101 DAVID P RALL BUILDING BG RM A222
111 TW ALEXANDER DR
DURHAM NC 27709
(984) 287-3647
janet.hall@nih.gov

Jennifer L. Emerson
National Institute of Environmental Health Sciences (NIEHS)
Social & Scientific Systems, Inc.
4505 Emperor Blvd Suite 400
Durham, NC 27703
(800) 860-3804
niehs-pegs-info@nih.gov

Jamie R. Glover
SOCIAL AND SCIENTIFIC SYSTEMS
4505 EMPEROR BLVD STE 400
DURHAM NC 27703
(919) 287-4382
jamie.glover@nih.gov

Clinical Trials Number:

NCT00341237

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