ALSNCT00340301
Exposure to Neurotoxins as Risk Factors for ALS
An observational study of ALS, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALS
- How many people
- 397 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2003to 23 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cases were eligible to participate in the original study if (1) they had received a diagnosis of ALS within 2 years; (2) they lived in New England at least half the year; (3) they spoke English; (4) they were mentally and physically able to participate. The same inclusion criteria were used for controls.
Who cannot join
- Potential controls were excluded if they had a physician diagnosis of a neurodegenerative disease, polio, post-polio syndrome, or nondiabetic neuropathy.
- Pregnant women were excluded from both case and control groups.
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Medical Center
Boston, Massachusetts, 02111
About this study
Official title: Exposure to Neurotoxins as Risk Factors for ALS: Measurement of Genes, Proteins, Neurotoxicants, and Other Factors Potentially Associated With ALS
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.
Read the 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 and/or 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.
- Conditions
- ALS
- Keywords
- Polymorphism, Neurodegenerative Diseases, ALS
- Medical subject headings
- Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement in blood or toenails of genes, proteins, neurotoxicants, and other factors or agents potentially associated with ALS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start3 Jun 2003
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Freya Kamel, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340301
- Sponsor's protocol ID
- 999903210
- Other IDs
- 03-E-N210
- Status last verified
- 23 Jan 2019
- First submitted
- 19 Jun 2006
- Last updated
- 25 Jan 2019
- Results posted
- No
Publications
Nelson LM. Epidemiology of ALS. Clin Neurosci. 1995-1996;3(6):327-31.
PubMed 9021253Shaw PJ. Motor neurone disease. BMJ. 1999 Apr 24;318(7191):1118-21. doi: 10.1136/bmj.318.7191.1118. No abstract available.
PubMed 10213726Mitchell JD. Amyotrophic lateral sclerosis: toxins and environment. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Sep;1(4):235-50. doi: 10.1080/14660820050515061.
PubMed 11465017
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Neurotoxins as Risk Factors for ALS: Measurement of Genes, Proteins, Neurotoxicants, and Other Factors Potentially Associated With ALS
- ClinicalTrials.gov ID
- NCT00340301
- Acronym / sponsor ID
- 999903210
- Conditions
- ALS
- Keywords
- Polymorphism, Neurodegenerative Diseases, ALS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 3 Jun 2003
- Study completion
- 23 Jan 2019
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and/or 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cases were eligible to participate in the original study if (1) they had received a diagnosis of ALS within 2 years; (2) they lived in New England at least half the year; (3) they spoke English; (4) they were mentally and physically able to participate. The same inclusion criteria were used for controls.
Key exclusion criteria (2 listed)
- Potential controls were excluded if they had a physician diagnosis of a neurodegenerative disease, polio, post-polio syndrome, or nondiabetic neuropathy.
- Pregnant women were excluded from both case and control groups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement in blood or toenails of genes, proteins, neurotoxicants, and other factors or agents potentially associated with ALS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 9021253Nelson LM. Epidemiology of ALS. Clin Neurosci. 1995-1996;3(6):327-31.
- Background: PubMed 10213726Shaw PJ. Motor neurone disease. BMJ. 1999 Apr 24;318(7191):1118-21. doi: 10.1136/bmj.318.7191.1118. No abstract available.
- Background: PubMed 11465017Mitchell JD. Amyotrophic lateral sclerosis: toxins and environment. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Sep;1(4):235-50. doi: 10.1080/14660820050515061.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freya Kamel, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement in blood or toenails of genes, proteins, neurotoxicants, and other factors or agents potentially associated with ALS. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340301, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.