NCT01041469

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 22, 2012

Status Verified

December 1, 2009

First QC Date

December 30, 2009

Last Update Submit

March 21, 2012

Conditions

Down Syndrome With and Without Auto Immune Abnormalities

Keywords

Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,

Outcome Measures

Primary Outcomes (2)

  • Auto-antibodies dosage

    at enrolment

  • specific lymphocytes populations count

    at enrolment

Study Arms (2)

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

Eligibility Criteria

Age8 Years - 36 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Jerome Lejeune

Paris, 75015, France

Location

Laboratoire d'Immunologie Biologique (Unité INSERM U580)

Paris, 75743, France

Location

Related Publications (1)

  • 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.

    PMID: 2528336BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and white cells

MeSH Terms

Conditions

Down SyndromeAutoimmune Diseases

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

November 1, 2009

Study Completion

December 1, 2010

Last Updated

March 22, 2012

Record last verified: 2009-12

Locations

FR(2)