ALSMETABALSNCT01962311
Evaluation of Metabolomic Analysis in Early Diagnosis of ALS
A study testing lumbar puncture in people with ALS, run by University Hospital, Tours at 6 sites in France.
Trial summary
This project is expected to answer the question of interest assays of metabolites in the CSF as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. These studies should also help shed light on the pathophysiological original early clinical disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- ALS
- What is being tested?
- lumbar puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 6 sitesFrance
- Study dates
- Feb 2013to Feb 2018
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 30-80
- Consent signed
- affiliation to a social security organism
Who cannot join
- Patients treated with RILUZOLE
- Enrollment in an other study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Pôle Neurosciences et Spécialités ,Service de Neurologie,CHU d'Angers
Angers, 49933
Service de Neurologie et Pathologie du Mouvement Clinique de Neurologie, Pôle des Neurosciences et de l'Appareil Locomoteur INSERM U 837
Lille, 59037
Centre de Recherche de l'Institut du Cerveau et de la moëlle UPMC Paris 6,Département des Maladies du Système Nerveux
Paris, 75013
Service de neurologie, CHU La Milétrie, POITIERS, Faculté de Médecine
Poitiers, 86021
University Hospital
Strasbourg, 67000
CHRU -TOURS-Service de Neurologie
Tours, 37044
About this study
This project is expected to answer the question of interest assays of metabolites in the CSF as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. These studies should also help shed light on the pathophysiological original early clinical disease. While ALS appears to be more a clinical syndrome that pathophysiological entity unique metabolic abnormalities identified could help identify mechanisms disrupted in which therapeutic interventions will be possible.
Read the detailed description
A blood test that would allow the diagnosis
- to reduce the time between the first signs and diagnosis in ALS patients for therapeutic treatment earlier and
- to exclude rapidly non ALS in their avoiding unnecessary investigations and anxiety of being infected with a terrible prognosis disease. It is currently accepted that neurodegenerative diseases such as ALS begin before the first clinical signs and the patient could benefit from a more efficient care if it was early.
Conduct a prospective study with 400 patients.
The secondary objectives are:
- attempt to improve the predictive power of markers assays by adding new parameters
- to check whether the assayed molecules in other environments more accessible (blood, urine) would provide equivalent diagnostic power of those assayed in the CSF
- identify metabolic pathways disrupted early that could be related to the pathogenesis of neurodegeneration.
- Conditions
- ALS
- Being tested
- lumbar puncture
- Keywords
- ALS, Spinal Cerebrospinal Fluid, Urine, SERUM, Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar punctureProcedure or surgery
lumbar puncture at enrollment in study
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | lumbar puncture Receives: Procedure: lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods
diagnostic criteria Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods: GC / MS, LC / MSMS and proton NMR spectroscopy. These metabolites, the number of one hundred, can be grouped into four main groups: molecules of metabolism of carbohydrates, lipids, proteins, steroids
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian ANDRES, MD-PHD, Study director, University Hospital TOURS and INSERM U930
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962311
- Sponsor's protocol ID
- PHRN11-CA-METABALS
- Other IDs
- 2012-A00145-38
- Acronym
- METABALS
- Status last verified
- Jul 2019
- First submitted
- 15 Jan 2013
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolomic Analysis in Early Diagnosis of ALS
- ClinicalTrials.gov ID
- NCT01962311
- Acronym / sponsor ID
- METABALS / PHRN11-CA-METABALS
- Conditions
- ALS
- Keywords
- ALS, Spinal Cerebrospinal Fluid, Urine, SERUM, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Oct 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.
This project is expected to answer the question of interest assays of metabolites in the CSF as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. These studies should also help shed light on the pathophysiological original early clinical disease. While ALS appears to be more a clinical syndrome that pathophysiological entity unique metabolic abnormalities identified could help identify mechanisms disrupted in which therapeutic interventions will be possible.
Detailed description
A blood test that would allow the diagnosis
- to reduce the time between the first signs and diagnosis in ALS patients for therapeutic treatment earlier and
- to exclude rapidly non ALS in their avoiding unnecessary investigations and anxiety of being infected with a terrible prognosis disease. It is currently accepted that neurodegenerative diseases such as ALS begin before the first clinical signs and the patient could benefit from a more efficient care if it was early.
Conduct a prospective study with 400 patients.
The secondary objectives are:
- attempt to improve the predictive power of markers assays by adding new parameters
- to check whether the assayed molecules in other environments more accessible (blood, urine) would provide equivalent diagnostic power of those assayed in the CSF
- identify metabolic pathways disrupted early that could be related to the pathogenesis of neurodegeneration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Procedure: lumbar puncturelumbar puncture |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 30-80
- Consent signed
- affiliation to a social security organism
Key exclusion criteria (2 listed)
- Patients treated with RILUZOLE
- Enrollment in an other study
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 |
|---|---|---|
| lumbar puncturelumbar puncture at enrollment in study | Procedure or surgery | All patients |
Primary outcome
Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods
Time frame: 2 years
diagnostic criteria Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods: GC / MS, LC / MSMS and proton NMR spectroscopy. These metabolites, the number of one hundred, can be grouped into four main groups: molecules of metabolism of carbohydrates, lipids, proteins, steroids
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 17 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Christian ANDRES, MD-PHD study director
University Hospital TOURS and INSERM U930
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar puncture in people with ALS, run by University Hospital, Tours at 6 sites in France.
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 3 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 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods (time frame: 2 years). 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 17 Jul 2019.