Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Environmental Polymorphisms Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )
ClinicalTrials.gov Identifier:
NCT00341237
First received: June 19, 2006
Last updated: November 11, 2014
Last verified: September 2014
  Purpose

This study conducted by the NIEHS and the University of North Carolina Medical Center will create and maintain a biorespository containing the genetic material (DNA) from up to 20,000 individuals recruited from North Carolina. These samples will allow scientists to look for differences in each individual s DNA. These differences are not known to be associated with any condition or disease to date, but the purpose of the study is test these differences for possible susceptibility to (or protection to) common conditions such as asthma, cardiovascular disease, cancer and many others. Many of the differences to be studied are in environmental response genes. These genes determine the various ways humans respond to toxic substances in the environment, their diet and lifestyles (e.g. no exercise vs. exercise), and exposures to other substances, e.g. therapeutics.

Participants will be recruited from the general NC population through health fairs, studies drives at community venues and corporations, and from out patient clinics within the University of North Carolina health care system. Participants can also visit one of two locations in the Research Triangle area to volunteer for this study. All participants will be asked to provide a blood sample and some basic information on their gender, race and ethnicity, and will be compensated for their time by receiving $20.

DNA will be extracted from the blood, encrypted with a secret identification number, and placed in the registry's biorepository. The registry will exist for up to 25 years. During that time, the DNAs will be available to researchers to look for the differences in the DNAs as described above. Participants who have certain differences might be asked to participate in a future study of people with the same DNA differences. The future studies will most likely involve filling out a questionnaire or participating in a telephone survey, but may involve being interviewed or having a physical examination or laboratory evaluation, including blood tests. Participants will be asked to update their contact information once a year for up to 25 years.


Condition
Polymorphism

Study Type: Observational
Official Title: Environmental Polymorphism Registry (EPR)

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 20000
Study Start Date: November 2003
Detailed Description:

We are establishing a large biorepository of frozen DNA samples (n=20,000) in which the DNAs are linked to the donor s identities, contact information, and some basic demographics through a personal identification number (PIN). The DNAs will be made available to investigators in coded form to anonymously screen for the presence of SNPs and other mutations by standard genotyping methods. Once subjects with the genotypes of interest have been identified, investigators can apply for re-identification of the samples and ask the same subjects to participate in follow-up phenotyping studies in a process known as phenotype-by-genotype.

To investigate the feasibility of this large project named the Environmental Polymorphism Registry (EPR), we first conducted a pilot study (Environmental Polymorphisms Study or EPS) at two University of North Carolina (UNC) Healthcare clinics. The goals of the EPS were to assess the willingness of outpatients to participate in a genetic study of this sort and identify potential problems that might arise when conducting the much larger 20,000-sample EPR. In the EPS, recruitment rates were high at both sites; 77% of patients approached while having their blood drawn for clinical testing agreed to participate by signing the informed consent form (ICF) and donating their leftover blood. Based on these results, we decided to proceed with the EPR. Since the EPS (pilot study) subjects and their samples have been incorporated into the larger EPR and will be used similarly, the EPS and EPR protocols were merged into this one protocol.

EPR subjects will be recruited from North Carolina from the NIEHS Clinical Research Unit (CRU), various healthcare clinics, and the general public. The latter includes university campuses, health fairs, study drives held at various locations (corporations, community centers, community events, etc.) and the EPR website. Subjects will be asked to donate blood for DNA isolation and archiving. They will go through an extensive ICF process in which they are told about the uncertain uses of their samples in genetic screening projects and the possibility of being recontacted for voluntary follow-up studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION AND EXCLUSION CRITERIA:

The only exclusion criteria is age. Participants must be greater than or equal to 18 years of age. Otherwise, there are no health status criteria for participating in this study; participants may be healthy or have preexisting conditions.

Participants will not be excluded based on gender, ethnicity, race or religion.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341237

Contacts
Contact: Shepherd H Schurman, M.D. (919) 541-7736 schurmansh@mail.nih.gov

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7030
Rex UNC Health Care Center Recruiting
Raleigh, North Carolina, United States, 27607
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States
Contact: Stavros Garantziotis, M.D.    919-541-0985    garantziotis@niehs.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Shepherd H Schurman, M.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )
ClinicalTrials.gov Identifier: NCT00341237     History of Changes
Other Study ID Numbers: 040053, 04-E-0053
Study First Received: June 19, 2006
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Polymorphism
Genotype
Phenotype
Environmental Factor
Single Nucleotide Polymorphism

ClinicalTrials.gov processed this record on November 25, 2014