Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

Completed

• Conditions: Down Syndrome With and Without Auto Immune Abnormalities

• Registration Number: NCT01041469
• Lead Sponsor: Institut Jerome Lejeune

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Status Verified: 2009-12
• Study First Submitted: 2009-12-30
• Study First Submitted QC: 2009-12-30
• Study First Posted: 2009-12-31
• Study Completion: 2010-12
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Auto-antibodies dosage	at enrolment
specific lymphocytes populations count	at enrolment

Trial Locations

Locations (2)

Institut Jerome Lejeune; 🇫🇷 Paris, France

Laboratoire d'Immunologie Biologique (Unité INSERM U580); 🇫🇷 Paris, France