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

This study has been completed.
Sponsor:
Collaborator:
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune
ClinicalTrials.gov Identifier:
NCT01041469
First received: December 30, 2009
Last updated: March 21, 2012
Last verified: December 2009
  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 ] [ Designated as safety issue: No ]
  • specific lymphocytes populations count [ Time Frame: at enrolment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   8 Years to 36 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 30, 2009
Last Updated: March 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Congenital Abnormalities
Down Syndrome
Syndrome
Abnormalities, Multiple
Chromosome Disorders
Disease
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014