Autism Spectrum DisorderREGUYAUTNCT02903732
Autism Registry for French Guiana
An observational study of Autism Spectrum Disorder, run by Centre Hospitalier de Cayenne at 1 site in France.
Trial summary
The objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a… Read more about this study
- Who is it for?
- Ages 8 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- observational
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 2020
- How long will I take part?
- 10 Years
- 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 8 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: children aged 8 years will be the denominator. the numerator is children who are seeking assistance for care or educational purposes at the unique administration dealing with handicap in French Guiana
Who may be able to join
- children aged 8 years with a diagnosis of autism spectrum disorder
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Cayenne
Cayenne, French Guiana, 97306
Mathieu Nacher, MD, PhD, 0594395024 ext. 5024, mathieu.nacher@ch-cayenne.fr
About this study
The objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a territory with significant structural deficits relative to mainland France. The outcomes of this registry will be to guide decision makers in their funding priorities to improve, screening, diagnosis, care and education for children on the autistic spectrum
- Conditions
- Autism Spectrum Disorder
- Being tested
- observational
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
registry
What is being measured
The primary outcome is the main question the study is designed to answer.
autism spectrum disorder
the number of 8 year old children with a diagnosis of autism spectrum disorder in a given year relative to the total population of children aged 8 years old in that given year
Measured: 1 year (the year at age 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903732
- Sponsor's protocol ID
- REGUYAUT
- Acronym
- REGUYAUT
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Registry for French Guiana
- ClinicalTrials.gov ID
- NCT02903732
- Acronym / sponsor ID
- REGUYAUT / REGUYAUT
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 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 objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a territory with significant structural deficits relative to mainland France. The outcomes of this registry will be to guide decision makers in their funding priorities to improve, screening, diagnosis, care and education for children on the autistic spectrum
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 8 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children aged 8 years will be the denominator. the numerator is children who are seeking assistance for care or educational purposes at the unique administration dealing with handicap in French Guiana
Key inclusion criteria (1 listed)
- children aged 8 years with a diagnosis of autism spectrum disorder
Key exclusion criteria (1 listed)
- refusal to participate
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 |
|---|---|---|
| observationalregistry | Other | – |
Primary outcome
autism spectrum disorder
Time frame: 1 year (the year at age 8)
the number of 8 year old children with a diagnosis of autism spectrum disorder in a given year relative to the total population of children aged 8 years old in that given year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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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.
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 Autism Spectrum Disorder, run by Centre Hospitalier de Cayenne at 1 site 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 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: status not confirmed, as of the sponsor's last update on 16 Sep 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autism spectrum disorder (time frame: 1 year (the year at age 8)). 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 16 Sep 2016.