Pilot Study of Auto-immune Abnormalities Associated With... | NCT01041469

Studies
Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

NCT01041469

Sponsor

Institut Jerome Lejeune

Status

Completed

Last Update Posted

Mar 22, 2012Estimated

Enrollment

72Actual

Phase

Not provided

Conditions

Down Syndrome With and Without Auto Immune Abnormalities

Interventions

Not provided

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Not provided

Completion Date

Dec 2010Actual

First Submitted Date

Dec 30, 2009

First Submission Date that Met QC Criteria

Dec 30, 2009

First Posted Date

Dec 31, 2009Estimated

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

Mar 21, 2012

Last Update Posted Date

Mar 22, 2012Estimated

Name	Class
Fondation Jérôme Lejeune	OTHER

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with abnormalities		Down syndrome patients presenting with at least one sign of auto immune abnormality
without abnormality		Down syndrome patients without any sign of recognized auto immune condition

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Auto-antibodies dosage		at enrolment
specific lymphocytes populations count		at enrolment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Free and complete trisomy 21
aged between 8 and 36 years
biological or clinical signs of auto-immune disorder (group 1)
no sign of auto-immune disorder (group 2)

Exclusion Criteria:

any antimitotic or immune depressing treatment during the last 6 months
Current infectious disease
Corticosteroid therapy in the last 3 weeks
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

36 Years

Standard Ages

ChildAdult

Study Population

Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally retarded children and adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Jerome Lejeune		Paris		75015	France
Laboratoire d'Immunologie Biologique (Unité INSERM U580)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2528336	Background	Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3.

ID	Term
D004314	Down Syndrome
D001327	Autoimmune Diseases

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases