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Personalized Environment and Genes Study

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ClinicalTrials.gov Identifier: NCT00341237
Recruitment Status : Recruiting
First Posted : June 21, 2006
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

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
Diabetes Heart Disease Asthma

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Personalized Environment and Genes Study
Actual Study Start Date : May 26, 2010

Resource links provided by the National Library of Medicine


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:   18 Years to 130 Years   (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:
  • 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.


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 niehs-pegs-info@nih.gov
Contact: Janet E Hall, M.D. (984) 287-3647 janet.hall@nih.gov

Locations
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United States, North Carolina
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States
Contact: Jamie Glover    800-860-3804    jamie.glover@nih.gov   
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Janet E Hall, M.D. National Institute of Environmental Health Sciences (NIEHS)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: August 4, 2022
Last Verified: July 13, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .There is no plan to make data dictionaries available.@@@@@@Personal information will be shared with researchers under this protocol, only if they meet one of three requirements: 1) they have an IRB-approved study protocol that has received approval from the PEGS Internal Advisory Committee or PEGS PI (for NIEHS investigators only); or 2) they have an IRB-approved study protocol listed in Appendix C as of 11/20/20; or 3) they have obtained IRB approval for a new protocol.@@@@@@Demographic information (e.g., age, gender, race, and ethnicity) will be shared with IRB-approved researchers conducting genotyping, exposure, or disease-specific callback studies, and these data will be labeled only with PEGS PINs. Pediatric participants data will be accessible to researchers in accordance with PEGS policies and procedures. DNA samples that are shared with researchers will be labeled only with the PEGS PIN.

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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
Natural History
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases