Amyotrophic Lateral SclerosisSLA-DOMNCT03367650
Epidemiology and Genetics of the Amyotrophic Lateral Sclerosis in the French West Indies
A study testing Blood sample and environmental survey in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
Trial summary
The diagnosis and the follow-up of the patients reached of SLA is centralized, since a few years, at the the Caribbean Reference center of the rare neurological diseases (CERCA labélisé in 2006) in Martinique and at the Unity of coverage of the neuromuscular Diseases, SLA and the rare neurological diseases (create in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Blood sample and environmental survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 May 2014to 13 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or third-party responsible for receiving information on the study and who signed informed consent ;
- Patient age over 18 years;
- Patient living in the Antilles;
- Patient with ALS or SLP (primary lateral sclerosis, pure central form of ALS).
Who cannot join
- Patient non-affiliated to the social security scheme ;
- in case of difficulty of monitoring patient, exclusion of the longitudinal study.
Trial locations and contacts
2 sites in 2 countries.
Chantal LERUS, Director of Clinical Research contact
2 sites in 2 countries
Guadeloupe1 site, 1 recruiting
- Recruiting
Hospital University Center of Pointe-à-Pitre
Pointe-à-Pitre, 97159
Chantal LERUS, Director of Clinical Research, 0590 93 46 86 ext. (+590), chantal.lerus@chu-guadeloupe.fr
Valérie SOTER, Manager of Reseach, 0590 93 46 86 ext. (+590), valerie.soter@chu-guadeloupe.fr
Martinique1 site, 1 recruiting
- Recruiting
Hospital University Center of Martinique
Fort-de-France, 97261
Chantal LERUS, Director of Clinical Research, 0590 93 46 86 ext. (+590), chantal.lerus@chu-guadeloupe.fr
Valerie SOTER, Manager of Reseach, 0590 93 46 86 ext. (+590), valerie.soter@chu-guadeloupe.fr
About this study
The diagnosis and the follow-up of the patients reached of SLA is centralized, since a few years, at the the Caribbean Reference center of the rare neurological diseases (CERCA labélisé in 2006) in Martinique and at the Unity of coverage of the neuromuscular Diseases, SLA and the rare neurological diseases (create in 2010) in Guadeloupe. Several phenotypic characteristics seemed to us to take out again data collected during the follow-up of the patients (26 in Guadeloupe, since the creation of the unity) in particular patients' high proportion of exceptionally long evolution (more than 10 years). Besides, we diagnosed several cases (10 cases in Guadeloupe since 2000) of association SLA- Parkinsonien Syndrome.
This association, considered as exceptional could establish a particular phenotypic entity which we would like to describe. We are interested also originally geographical of the patients, with the hypothesis that he could exist in the Antilles one or several geographical isolates of the disease allowing to lead a étiologique investigation in search of a possible genetic or environmental cause.
Read the detailed description
The amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive muscular paralysis due to degeneration of motor neurons in the primary motor cortex, corticospinal pathway, brain stem and spinal cord. The incidence is estimated at 2/100 000 per year and prevalence at approximately 4/100000.
Various clinical forms are described. The disease is fatal is 3-5 years on average.
The majority of cases are sporadic and of unknown origin but 5-10% are familial and present for 20% of them, mutations in the SOD1 (21q22.11) gene. Other genes have recently been implicated in ALS. Environmental toxic factors have been extensively researched. Beta-methylamino-L-alanine (BMAA), a neurotoxic nonprotein amino acid produced by most cyanobacteria, has been proposed to be the causative agent of the ALS-Parkinsonism Complex on the island of Guam in the Pacific Ocean.
Epidemiology and clinical features of ALS have never been studied in Caribbean countries.
The main purpose of the study will be to evaluate the incidence of ALS in Guadeloupe and Martinique.
Secondary purposes will be:
- to evaluate the presence of specific phenotypic features;
- to establish he prognosis of different clinical forms;
- to study the genes implicated in ALS and quantify theexposure to BMAA.
Since 2000, the diagnosis of ALS is made in about 20 patients per year in Guadeloupe and Martinique(for a total population of 800000 inhabitants) but the incidence and the clinical presentation of ALS in the French West Indiesare unknown.
The exceptional association of ALS and parkinsonism is regularly observed in Guadeloupe. We propose to perform a prospective descriptive and longitudinal epidemiological study to determine the incidence of ALSin the French West Indies. In parallel we will study the involvement of genetic andenvironmental toxic factors as etiological factor for this disease.
Primary outcome:
- the impact of ALS in Guadeloupe and Martinique
Secondary outcomes:
- Assess the clinical characteristics (presence of phenotypic features?),
- the prognosis of different clinical forms study,
- to establish the genetic factors of the ALS and to search potential environmental factors
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Blood sample and environmental survey
- Keywords
- amyotrophic lateral sclerosis, epidemiology, genetic, environmental factor
- 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.
Blood sample and environmental surveyDietary supplement
The intervention corresponds to a 10 ml of Blood sample and an environmental survey.
| Study group | Role | What they receive |
|---|---|---|
| ALS's patients in Guadeloupe and Martinique | Other | We shall determine:
* Impact of ALS in Guadeloupe and Martinique
* Prevalence of the ALS in Guadeloupe and Martinique on the duration of the study
* The distribution of ALS various phenotypes in our population of patients.
* We shall collect the date of the beginning of the symptoms of the SLA, the date of diagnosis of ALS, the date of death for the same individual and the origin of the death, the weight, the size, the albumin, CRP; in order to establish the forecast of the various clinical forms, the description of the evolution of the nutritional state.
* Search for transfers of genes TARDBP, VCP, SOD1 known and involved in the disease
* Search for possible environmental factors Receives: Dietary Supplement: Blood sample and environmental survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of amyotrophic lateral sclerosis in Guadeloupe and Martinique
Number of new cases per year.
Measured: Through study completion, an average of 6 years
Secondary outcomes (3)
Estimate prevalence of the ALS
Determine the total number of case of ALS diagnosed in Guadeloupe and Martinique on the duration of the study
Measured: Through study completion, an average of 6 years
Clinical criteria of SLA
General, neurological, digestive clinical examination and cardiorespiratory complete and the realization of the score " ALS funtional rating scale "
Measured: Through study completion, an average of 9 years
Study the genetic factors of the ALS
Search for transfers of genes TARDBP, VCP, SOD1:
According to the genealogical data, we shall target the possible family forms to test at these patient's the various genes known and involved in the disease (transfers of the gene SOD1 (21q22.11), of the gene TARDBP (1p36.22) coding the protein TAR DNA-binding protein 43 (TDP-43) and of the gene VCP (9p13.3) coding for the protein Valosin Containing Protein).
For the sporadic cases the analysis of these genes will be realized on the whole studied population.
For the family cases the genetic study will be spread in the whole family.
Measured: Through study completion, an average of 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start13 May 2014
- Primary completion13 May 2020 (estimated)
- Study completion13 May 2023 (estimated)
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.
- 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
- Model description
- Bi-centric epidemiological prospective, cross-sectional descriptive study coupled with a longitudinal study.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annie LANNUZEL, Professor, Neurological, Study director, Hospital University Center of Pointe-à-Pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367650
- Sponsor's protocol ID
- RBM-PAP-2013/55
- Acronym
- SLA-DOM
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Genetics of the Amyotrophic Lateral Sclerosis in the French West Indies
- ClinicalTrials.gov ID
- NCT03367650
- Acronym / sponsor ID
- SLA-DOM / RBM-PAP-2013/55
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, epidemiology, genetic, environmental factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 13 May 2014 (actual)
- Primary completion
- 13 May 2020 (estimated)
- Study completion
- 13 May 2023 (estimated)
- First posted
- 11 Dec 2017 (actual)
- 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 diagnosis and the follow-up of the patients reached of SLA is centralized, since a few years, at the the Caribbean Reference center of the rare neurological diseases (CERCA labélisé in 2006) in Martinique and at the Unity of coverage of the neuromuscular Diseases, SLA and the rare neurological diseases (create in 2010) in Guadeloupe. Several phenotypic characteristics seemed to us to take out again data collected during the follow-up of the patients (26 in Guadeloupe, since the creation of the unity) in particular patients' high proportion of exceptionally long evolution (more than 10 years). Besides, we diagnosed several cases (10 cases in Guadeloupe since 2000) of association SLA- Parkinsonien Syndrome.
This association, considered as exceptional could establish a particular phenotypic entity which we would like to describe. We are interested also originally geographical of the patients, with the hypothesis that he could exist in the Antilles one or several geographical isolates of the disease allowing to lead a étiologique investigation in search of a possible genetic or environmental cause.
Detailed description
The amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive muscular paralysis due to degeneration of motor neurons in the primary motor cortex, corticospinal pathway, brain stem and spinal cord. The incidence is estimated at 2/100 000 per year and prevalence at approximately 4/100000.
Various clinical forms are described. The disease is fatal is 3-5 years on average.
The majority of cases are sporadic and of unknown origin but 5-10% are familial and present for 20% of them, mutations in the SOD1 (21q22.11) gene. Other genes have recently been implicated in ALS. Environmental toxic factors have been extensively researched. Beta-methylamino-L-alanine (BMAA), a neurotoxic nonprotein amino acid produced by most cyanobacteria, has been proposed to be the causative agent of the ALS-Parkinsonism Complex on the island of Guam in the Pacific Ocean.
Epidemiology and clinical features of ALS have never been studied in Caribbean countries.
The main purpose of the study will be to evaluate the incidence of ALS in Guadeloupe and Martinique.
Secondary purposes will be:
- to evaluate the presence of specific phenotypic features;
- to establish he prognosis of different clinical forms;
- to study the genes implicated in ALS and quantify theexposure to BMAA.
Since 2000, the diagnosis of ALS is made in about 20 patients per year in Guadeloupe and Martinique(for a total population of 800000 inhabitants) but the incidence and the clinical presentation of ALS in the French West Indiesare unknown.
The exceptional association of ALS and parkinsonism is regularly observed in Guadeloupe. We propose to perform a prospective descriptive and longitudinal epidemiological study to determine the incidence of ALSin the French West Indies. In parallel we will study the involvement of genetic andenvironmental toxic factors as etiological factor for this disease.
Primary outcome:
- the impact of ALS in Guadeloupe and Martinique
Secondary outcomes:
- Assess the clinical characteristics (presence of phenotypic features?),
- the prognosis of different clinical forms study,
- to establish the genetic factors of the ALS and to search potential environmental factors
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bi-centric epidemiological prospective, cross-sectional descriptive study coupled with a longitudinal study.
| Arm | Type | Receives |
|---|---|---|
| ALS's patients in Guadeloupe and Martinique | Other | Dietary Supplement: Blood sample and environmental surveyWe shall determine: * Impact of ALS in Guadeloupe and Martinique * Prevalence of the ALS in Guadeloupe and Martinique on the duration of the study * The distribution of ALS various phenotypes in our population of patients. * We shall collect the date of the beginning of the symptoms of the SLA, the date of diagnosis of ALS, the date of death for the same individual and the origin of the death, the weight, the size, the albumin, CRP; in order to establish the forecast of the various clinical forms, the description of the evolution of the nutritional state. * Search for transfers of genes TARDBP, VCP, SOD1 known and involved in the disease * Search for possible environmental factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient or third-party responsible for receiving information on the study and who signed informed consent ;
- Patient age over 18 years;
- Patient living in the Antilles;
- Patient with ALS or SLP (primary lateral sclerosis, pure central form of ALS).
Key exclusion criteria (2 listed)
- Patient non-affiliated to the social security scheme ;
- in case of difficulty of monitoring patient, exclusion of the longitudinal 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 |
|---|---|---|
| Blood sample and environmental surveyThe intervention corresponds to a 10 ml of Blood sample and an environmental survey. | Dietary supplement | ALS's patients in Guadeloupe and Martinique |
Primary outcome
the impact of amyotrophic lateral sclerosis in Guadeloupe and Martinique
Time frame: Through study completion, an average of 6 years
Number of new cases per year.
3 secondary outcomes
Estimate prevalence of the ALS
Time frame: Through study completion, an average of 6 years
Clinical criteria of SLA
Time frame: Through study completion, an average of 9 years
Study the genetic factors of the ALS
Time frame: Through study completion, an average of 9 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- 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.
Chantal LERUS, Director of Clinical Research contact
Annie LANNUZEL, Professor, Neurological study director
Hospital University Center of Pointe-à-Pitre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and environmental survey in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe, Martinique. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chantal LERUS, Director of Clinical Research (0590 93 46 86 ext. (+590), chantal.lerus@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the impact of amyotrophic lateral sclerosis in Guadeloupe and Martinique (time frame: Through study completion, an average of 6 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 11 Dec 2017.