Amyotrophic Lateral SclerosisCleveland OhioNCT02916966
Environmental Exposure and Neurological Diseases Questionnaire
An observational study of Amyotrophic Lateral Sclerosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Patient Registry
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2023
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. ALS patients in case-control at CCF 2. Non-neurodegenerative patients in case control at CCF 3. Non-neurodegenerative general population in Ohio 4. ALS patient registry in Ohio
Who may be able to join
- ALS
- Non-neurodegenerative controls
- Can willingly give consent
- Over 18 years of age
Who cannot join
- Cannot give consent
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case-control and Population Questionnaire Studying Environmental Risk Factors and Neurological Diseases
The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be compared with the national and State-Metro Surveillance Programs of the National ALS Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA (beta-methylamino-L-alanine), and other environmental toxins/toxicants as risk factors for ALS. This work will advance the mission of the Centers for Disease Control Agency for Toxic Substances and Disease Registry (CDC ATSDR) National ALS Registry by offering data on ALS cases in Ohio that address public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake Erie.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Patient Registry
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient RegistryOther
Patient Registry
| Study group | Role | What they receive |
|---|---|---|
| ALS Patients in Case-Control | ALS patients enrolled by Cleveland Clinic Foundation (CCF) Receives: Other: Patient Registry | |
| Non-neurodegenerative patients in case control | Non-neurodegenerative patients enrolled by CCF Receives: Other: Patient Registry | |
| Non-neurodegeneration population in population control | Non-neurodegenerative general population enrolled by ABS mailing system from DHMC Receives: Other: Patient Registry | |
| ALS Patients in State of OH | ALS registry of all cases in Ohio Receives: Other: Patient Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire for Environmental Exposures, Toxins, and Neurological Disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2023
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Elijah W. Stommel, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916966
- Sponsor's protocol ID
- D06019
- Acronym
- Cleveland Ohio
- Status last verified
- Apr 2024
- First submitted
- 26 Sep 2016
- Last updated
- 1 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control and Population Questionnaire Studying Environmental Risk Factors and Neurological Diseases
- ClinicalTrials.gov ID
- NCT02916966
- Acronym / sponsor ID
- Cleveland Ohio / D06019
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 28 Sep 2016 (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.
The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be compared with the national and State-Metro Surveillance Programs of the National ALS Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA (beta-methylamino-L-alanine), and other environmental toxins/toxicants as risk factors for ALS. This work will advance the mission of the Centers for Disease Control Agency for Toxic Substances and Disease Registry (CDC ATSDR) National ALS Registry by offering data on ALS cases in Ohio that address public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake Erie.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALS Patients in Case-Control | – | Other: Patient RegistryALS patients enrolled by Cleveland Clinic Foundation (CCF) |
| Non-neurodegenerative patients in case control | – | Other: Patient RegistryNon-neurodegenerative patients enrolled by CCF |
| Non-neurodegeneration population in population control | – | Other: Patient RegistryNon-neurodegenerative general population enrolled by ABS mailing system from DHMC |
| ALS Patients in State of OH | – | Other: Patient RegistryALS registry of all cases in Ohio |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. ALS patients in case-control at CCF 2. Non-neurodegenerative patients in case control at CCF 3. Non-neurodegenerative general population in Ohio 4. ALS patient registry in Ohio
Key inclusion criteria (4 listed)
- ALS
- Non-neurodegenerative controls
- Can willingly give consent
- Over 18 years of age
Key exclusion criteria (2 listed)
- Cannot give consent
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient RegistryPatient Registry | Other | ALS Patients in Case-Control, ALS Patients in State of OH, Non-neurodegeneration population in population control, Non-neurodegenerative patients in case control |
Primary outcome
Questionnaire for Environmental Exposures, Toxins, and Neurological Disease
Time frame: 1 year
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 1 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amyotrophic Lateral Sclerosis, run by Dartmouth-Hitchcock Medical Center 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 4 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 1 May 2024. 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?
Questionnaire for Environmental Exposures, Toxins, and Neurological Disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2024.