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NCT00340886 · ClinicalTrials.gov registry record
NIEHS/UNC Environmental Polymorphism Study
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 485
- Enrollment target
NCT00340886: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00340886 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 485 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00340886 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 485 participants
- Enrollment target
Study Summary
The Environmental Genome Project (EGP) has completely or partially resequenced the protein coding and regulatory regions of 53 environmentally sensitive genes from 72 anonymous individuals of varying ethnic backgrounds to date. Some of the same genes have been resequenced in an additional set of 20 samples, and, in a subset of these, the introns and promoter regions have been sequenced as well. Within this population, 523 allelic variants (genetic polymorphisms), mostly single nucleotide polymorphisms (SNPs), have been found to date. If the polymorphism alters the behavior or expression of the encoded protein, it might be of clinical significance. The Office of Clinical Research is planning to establish a large resource bank of frozen DNA samples (20,000) and make it available to NIEHS intramural investigators involved in the EGP to screen for the presence of these SNPs and other mutations by standard genotyping methods. To investigate the feasibility of such a large collection of samples, we plan to first conduct a pilot study to estimate the accrual rate and uncover potential problems that may be encountered in the larger effort. This IRB proposal is for the pilot study in which we will collect whole blood samples (EDTA-anticoagulated) from 481 patients at UNC Medical Center. Once the pilot study is complete, we will decide whether to proceed with the larger, 20,000 sample collection and if so, develop and submit for review a new IRB protocol for its implementation taking date from the pilot study into account. For both the pilot study and larger, 20,000 sample collection, only blood left over from patients already having their blood drawn for hematology (complete blood count or CBC) assays as part of their routine clinical management will be used, thus eliminating the need to collect extra blood. Once the samples have been obtained from the clinical hematology laboratory and processed, they will be identifiable only with a unique identification number and sent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2001-10-01 |
| Est. Completion | 2010-05-19 |
What the finished NCT00340886 record still lists
NCT00340886 is an observational study that tracks outcomes without assigning an intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00340886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00340886 about?
NCT00340886 is a clinical study titled "NIEHS/UNC Environmental Polymorphism Study". The Environmental Genome Project (EGP) has completely or partially resequenced the protein coding and regulatory regions of 53 environmentally sensitive genes from 72 anonymous individuals of varying ethnic backgrounds to date. Some of the same genes have been resequenced in an additional set of 20 ...
What is the current status of trial NCT00340886?
This trial is currently completed. The enrollment target is 485 participants. The study started on 2001-10-01. Estimated completion is 2010-05-19.
Who is sponsoring clinical trial NCT00340886?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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