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Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome (IMMUTRI)

This study has been completed.
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune Identifier:
First received: December 30, 2009
Last updated: March 21, 2012
Last verified: December 2009
The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.

Down Syndrome With and Without Auto Immune Abnormalities

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

Resource links provided by NLM:

Further study details as provided by Institut Jerome Lejeune:

Primary Outcome Measures:
  • Auto-antibodies dosage [ Time Frame: at enrolment ]
  • specific lymphocytes populations count [ Time Frame: at enrolment ]

Biospecimen Retention:   Samples With DNA
whole blood and white cells

Enrollment: 72
Study Start Date: November 2009
Study Completion Date: December 2010
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


Ages Eligible for Study:   8 Years to 36 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally retarded children and adults

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01041469

Institut Jerome Lejeune
Paris, France, 75015
Laboratoire d'Immunologie Biologique (Unité INSERM U580)
Paris, France, 75743
Sponsors and Collaborators
Institut Jerome Lejeune
Fondation Jérôme Lejeune
  More Information

Responsible Party: Institut Jerome Lejeune Identifier: NCT01041469     History of Changes
Other Study ID Numbers: IJL-IMM-EP10
Study First Received: December 30, 2009
Last Updated: March 21, 2012

Keywords provided by Institut Jerome Lejeune:
Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,

Additional relevant MeSH terms:
Congenital Abnormalities
Down Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Chromosome Disorders
Genetic Diseases, Inborn processed this record on August 22, 2017