Viewing Study NCT00044590



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00044590
Status: COMPLETED
Last Update Posted: 2017-05-16
First Post: 2002-09-03

Brief Title: Parkinsons Diseases Susceptibility Genes and Pesticides
Sponsor: National Institute of Environmental Health Sciences NIEHS
Organization: National Institute of Environmental Health Sciences NIEHS

Study Overview

Official Title: Parkinsons Diseases Susceptibility Genes and Pesticides
Status: COMPLETED
Status Verified Date: 2017-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Parkinsons disease PD occurrence is higher in rural than in urban populations of industrialized countries Epidemiologic and human tissue studies suggest that pesticides may be responsible for causing dopaminergic cell death at increased rates While many pathophysiologic pathways may be involved in the neurodegeneration responsible for PD genetic factors are likely to determine a general susceptibility to neurodegeneration
Detailed Description: While many pathophysiologic pathways may be involved in the neurodegeneration responsible for PD genetic factors are likely to determine a general susceptibility to neurodegeneration There are a number of genetic polymorphisms of genes such as those coding for the cytochrome p450 super-family of genes referred to as susceptibility genes However they are generally not sufficient to cause disease unless a person encounters exposure to an environmental toxin the disease is caused by a gene-environment interaction Thus it is imperative to assess genetic susceptibility in individuals exposed to a toxin We will test the gene-environment interaction hypothesis by conducting an epidemiologic population-based case-control study of newly diagnosed PD patients from three rural California counties Kern Fresno and Tulare Over a four year period we expect to collect 400 cases referred to us by local neurologists farm worker clinics and Parkinsons foundations For each case one population control will be selected at random from residential parcel maps and Medicare databases and in addition one unaffected sibling control and - when possible - affected siblings to avoid potential biases and inefficiencies inherent in the use of each type of control For each study subject an environmental and occupational pesticide exposure estimate will be derived using California pesticide-use reporting PUR data and information about pesticide application on crops in combination with crop patterns shown in satellite images and aerial photographs in addition extensive exposure interviews will be conducted with all study subjects In a three-tiered approach to examine the effects of gene-environment interactions we will 1 test for association and linkage of PD to selected loci associated with PD in earlier studies using multiallelic repeat markers and genotyping 2 test for association using intragenic single nucleotide polymorphisms SNPs of 50 candidate genes arrayed to create the PD array and 3 use future technical possibilities to screen for genome wide associations using array technology to scan 5000-10000 SNPs throughout the genome Data analysis will employ hierarchical modeling procedures to take into account multiple comparison issues and to incorporate prior knowledge such as increased neurotoxicity due to the interaction of gene products and chemicals

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None