Personalized Environment and Genes Study

Sponsor

National Institute of Environmental Health Sciences (NIEHS) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT00341237

Collaborator

(none)

20,000

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

...

Condition or Disease	Intervention/Treatment	Phase
Diabetes Heart Disease Asthma

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Personalized Environment and Genes Study

Actual Study Start Date :

May 26, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Disease [End of study]
Genetic changes and disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 130 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.