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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041469
Recruitment Status : Completed
First Posted : December 31, 2009
Last Update Posted : March 22, 2012
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune

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

Condition or disease
Down Syndrome With and Without Auto Immune Abnormalities

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome
Study Start Date : November 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

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

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

Biospecimen Retention:   Samples With DNA
whole blood and white cells

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041469

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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

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Responsible Party: Institut Jerome Lejeune Identifier: NCT01041469     History of Changes
Other Study ID Numbers: IJL-IMM-EP10
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: December 2009
Keywords provided by Institut Jerome Lejeune:
Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,
Additional relevant MeSH terms:
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Down Syndrome
Congenital Abnormalities
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Chromosome Disorders
Genetic Diseases, Inborn