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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041469
First Posted: December 31, 2009
Last Update Posted: March 22, 2012
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.
Collaborator:
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune
  Purpose
The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.

Condition
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
Groups/Cohorts
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

Information from the National Library of Medicine

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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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01041469


Locations
France
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

Publications:
Responsible Party: Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT01041469     History of Changes
Other Study ID Numbers: IJL-IMM-EP10
First Submitted: December 30, 2009
First Posted: December 31, 2009
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:
Syndrome
Congenital Abnormalities
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Chromosome Disorders
Genetic Diseases, Inborn