Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

NCT ID: NCT01041469

Last Updated: 2012-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.

Detailed Description

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Conditions

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Down Syndrome With and Without Auto Immune Abnormalities

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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with abnormalities

Down syndrome patients presenting with at least one sign of auto immune abnormality

No interventions assigned to this group

without abnormality

Down syndrome patients without any sign of recognized auto immune condition

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Jérôme Lejeune

OTHER

Sponsor Role collaborator

Institut Jerome Lejeune

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Jerome Lejeune

Paris, , France

Site Status

Laboratoire d'Immunologie Biologique (Unité INSERM U580)

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 2528336 (View on PubMed)

Other Identifiers

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IJL-IMM-EP10

Identifier Type: -

Identifier Source: org_study_id

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