Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340301
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2006-06-19
Brief Title:
Exposure to Neurotoxins as Risk Factors for ALS
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Exposure to Neurotoxins as Risk Factors for ALS Measurement of Genes Proteins Neurotoxicants and Other Factors Potentially Associated With ALS
Status:
COMPLETED
Status Verified Date:
2019-01-23
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:
Chemicals called neurotoxins can harm the nervous system Amyotrophic lateral sclerosis ALS is a progressive disease affecting movement Researchers have studied many possible causes of ALS including injury diet and exposure to chemicals but these studies were inconclusive
The purpose of this study was to determine whether exposure to lead or other neurotoxins can contribute to ALS The study also evaluated lifestyle and dietary patterns The study was completed in 1994-1996
One hundred eighty-two participants took part in this study 110 patients with ALS and 72 who did not have ALS Each completed a questionnaire concerning lifestyle diet and residential job and medical history Participants contributed 50 cc of blood used to measure lead as well as clippings of their toenails used to measure mercury and other metals They then underwent an XRF test an X-ray procedure to measure the level of lead in their shinbones and knees Genes related to ALS or susceptibility to lead exposure were also evaluated
The purpose of this study was to determine whether exposure to lead or other neurotoxins can contribute to ALS The study also evaluated lifestyle and dietary patterns The study was completed in 1994-1996
One hundred eighty-two participants took part in this study 110 patients with ALS and 72 who did not have ALS Each completed a questionnaire concerning lifestyle diet and residential job and medical history Participants contributed 50 cc of blood used to measure lead as well as clippings of their toenails used to measure mercury and other metals They then underwent an XRF test an X-ray procedure to measure the level of lead in their shinbones and knees Genes related to ALS or susceptibility to lead exposure were also evaluated
Detailed Description:
OBJECTIVES Stored blood and toenail samples are available from a case-control study of ALS conducted in 1993-1996 The purpose of the initial study was to examine the relationship to ALS of lead and other exposures including mercury pesticides and solvents as well as genetic susceptibility to these exposures The protocol was closed in May 1997 closed protocol 95-007 after recruitment of study subjects ended The objective of the present proposal is to reopen the protocol to permit measurement in blood or toenails of genes proteins neurotoxicants and other factors or agents potentially associated with ALS as well as analyses of existing data The short-term goal is to measure i polymorphisms in DNA repair genes ii serum protein profiles and iii serum organochlorine pesticide levels Other factors may be of interest in the future for example polymorphisms in other genes or levels of metals in blood or toenails We also plan iv to continue analyses of existing data Some data analysis will involve combining data from the original ALS study with data from the Harvard Normative Aging Study a cohort study of World War II verterans that has collected demographic lifestyle and medical data as well as information on bone and blood lead levels
STUDY POPULATION No new subjects will be recruited for this protocol The original study involved 110 ALS cases 31 hospital controls with other neurologic diseases and 256 population controls recruited in New England between 1993 and 1996 The population controls were frequency matched to the cases on the basis of age gender race and region within New England
DESIGN The original study was a case-control study Data collection involved an interview collection of blood and toenail samples and measurement of bone lead using x-ray fluorescence Stored blood andor toenail samples are available from 107 ALS cases 31 hospital controls and 39 population controls The present study will use conventional techniques to measure genetic polymorphisms and serum organochlorine levels and newly developed SLDI-TOF technology to evaluate serum protein profiles
OUTCOME PARAMETERS The outcome parameter is risk of ALS Associations with ALS risk will be evaluated for polymorphisms in DNA repair genes serum protein profiles and organochlorine pesticide levels in serum
STUDY POPULATION No new subjects will be recruited for this protocol The original study involved 110 ALS cases 31 hospital controls with other neurologic diseases and 256 population controls recruited in New England between 1993 and 1996 The population controls were frequency matched to the cases on the basis of age gender race and region within New England
DESIGN The original study was a case-control study Data collection involved an interview collection of blood and toenail samples and measurement of bone lead using x-ray fluorescence Stored blood andor toenail samples are available from 107 ALS cases 31 hospital controls and 39 population controls The present study will use conventional techniques to measure genetic polymorphisms and serum organochlorine levels and newly developed SLDI-TOF technology to evaluate serum protein profiles
OUTCOME PARAMETERS The outcome parameter is risk of ALS Associations with ALS risk will be evaluated for polymorphisms in DNA repair genes serum protein profiles and organochlorine pesticide levels in serum
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-E-N210 | None | None | None |