Autism Registry for French Guiana | NCT02903732

Studies
Autism Registry for French Guiana

NCT02903732

Sponsor

Centre Hospitalier de Cayenne

Status

Unknown status

Last Update Posted

Sep 16, 2016Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

observational

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Dec 2020Estimated

First Submitted Date

Sep 6, 2016

First Submission Date that Met QC Criteria

Sep 13, 2016

First Posted Date

Sep 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2016

Last Update Posted Date

Sep 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
observational	Other	registry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 year (the year at age 8)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children aged 8 years with a diagnosis of autism spectrum disorder

Exclusion Criteria:

refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

8 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de Cayenne	Recruiting	Cayenne	French Guiana	97306	France

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided