Amyotrophic Lateral SclerosisWBCNCT01950910
Establishment of a Tissue Bank (Blood, CSF) for the Understanding of Motor Neuron Disease (MND)
An observational study of Amyotrophic Lateral Sclerosis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Biomarkers are essential for the identification of disease states. There are no early diagnostic or prognostic markers for ALS. The purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of ALS patients and to collect data to better understand disease progression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 766 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2004to 29 Oct 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ALS patients in the Charlotte, NC, area.
Who may be able to join
- 18 years old or older
Who cannot join
- less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurosciences Institute, Neurology - Charlotte
Charlotte, North Carolina, 28207
About this study
Official title: Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).
Biomarkers are essential for the identification of disease states. There are no early diagnostic or prognostic markers for ALS. The purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of ALS patients and to collect data to better understand disease progression.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early diagnostic test for ALS making identification of the disease difficult at its earliest stages. Early detection is critical to the initiation of early neuroprotective therapy. By the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. The purpose of the current project is to establish a bank of blood samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early diagnostic test for ALS and to better understand the progression of this disease.
Samples from patients that have a confirmed or unknown diagnosis of motor neuron disease will be examined. ALS and suspected neuromuscular disease (control) samples will be collected for comparison. Investigators will examine various biochemical, metabolic and genetic markers from these samples in hopes of finding differences in the expression between control subjects and ALS patients and how these biomarkers vary during disease progression. Participants will be asked to complete an optional questionnaire to collect data including medication and vitamin use and medical and disease history. This data will be linked to the patient's samples; however, all samples will be deidentified and coded to avoid the possibility of linking results to the patient. Results will not be stored in the patient's medical record.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, motor neuron disease, biological markers, biomarkers
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects w/ non-motor neurodegenerative disease | subjects with ALS or with non-motor neurodegenerative disease | |
| subjects w/out motorneuron degenerative dis | subjects without motorneuron degenerative disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of ALS biomarkers in blood
Blood samples will be processed to obtain serum samples and to isolate peripheral blood mononuclear cells (PBMC's). Serum samples will be analyzed for biochemical and metabolic markers of interest and future cell culture as needed. PBMCs will be processed for RNA, DNA or protein isolation. Aliquots of all samples will be stored for future study.
Measured: After blood is collected from study subjects. Data will be analyzed at one year.
Levels of ALS biomarkers in CSF
CSF samples will be processed and assayed for biomarkers of interest. An aliquot of CSF sample will be stored for future study.
Measured: After CSF is collected from study subject. Data will be analyzed at one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study start29 Mar 2004
- Primary completion31 Dec 2017
- Study completion29 Oct 2020
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 Wake Forest University Health SciencesThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin R Brooks, MD, Principal investigator, Neurosciences Institute, Neurology - Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950910
- Sponsor's protocol ID
- CHS-Neurology-WBC Tissue Bank
- Acronym
- WBC
- Status last verified
- Jul 2022
- First submitted
- 30 Mar 2013
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).
- ClinicalTrials.gov ID
- NCT01950910
- Acronym / sponsor ID
- WBC / CHS-Neurology-WBC Tissue Bank
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, motor neuron disease, biological markers, biomarkers
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 766 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 29 Mar 2004 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 26 Sep 2013 (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.
Biomarkers are essential for the identification of disease states. There are no early diagnostic or prognostic markers for ALS. The purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of ALS patients and to collect data to better understand disease progression.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early diagnostic test for ALS making identification of the disease difficult at its earliest stages. Early detection is critical to the initiation of early neuroprotective therapy. By the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. The purpose of the current project is to establish a bank of blood samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early diagnostic test for ALS and to better understand the progression of this disease.
Samples from patients that have a confirmed or unknown diagnosis of motor neuron disease will be examined. ALS and suspected neuromuscular disease (control) samples will be collected for comparison. Investigators will examine various biochemical, metabolic and genetic markers from these samples in hopes of finding differences in the expression between control subjects and ALS patients and how these biomarkers vary during disease progression. Participants will be asked to complete an optional questionnaire to collect data including medication and vitamin use and medical and disease history. This data will be linked to the patient's samples; however, all samples will be deidentified and coded to avoid the possibility of linking results to the patient. Results will not be stored in the patient's medical record.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects w/ non-motor neurodegenerative disease | – | –subjects with ALS or with non-motor neurodegenerative disease |
| subjects w/out motorneuron degenerative dis | – | –subjects without motorneuron degenerative disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ALS patients in the Charlotte, NC, area.
Key inclusion criteria (1 listed)
- 18 years old or older
Key exclusion criteria (1 listed)
- less than 18 years old
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
Levels of ALS biomarkers in blood
Time frame: After blood is collected from study subjects. Data will be analyzed at one year.
Blood samples will be processed to obtain serum samples and to isolate peripheral blood mononuclear cells (PBMC's). Serum samples will be analyzed for biochemical and metabolic markers of interest and future cell culture as needed. PBMCs will be processed for RNA, DNA or protein isolation. Aliquots of all samples will be stored for future study.
Levels of ALS biomarkers in CSF
Time frame: After CSF is collected from study subject. Data will be analyzed at one year.
CSF samples will be processed and assayed for biomarkers of interest. An aliquot of CSF sample will be stored for future study.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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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.
Benjamin R Brooks, MD principal investigator
Neurosciences Institute, Neurology - Charlotte
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 Wake Forest University Health Sciences 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 1 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: stopped early, as of the sponsor's last update on 11 Jul 2022. 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 was stopped early. Results are not available in the source record.
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?
Levels of ALS biomarkers in blood (time frame: After blood is collected from study subjects. Data will be analyzed at one year.). The study lists 2 primary outcomes in all. 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 11 Jul 2022.