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Completed

NCT Number: NCT01041469

Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

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

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Key information

Conditions

Down Syndrome With and Without Auto Immune Abnormalities Abnormalities, Multiple Autoimmune Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Immune System Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

8 year–36 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Jerome Lejeune, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Auto-antibodies dosage

    Time frame: at enrolment

  2. specific lymphocytes populations count

    Time frame: at enrolment

Sponsors and collaborators

Lead sponsor

Institut Jerome Lejeune

Other

Collaborators

  • Fondation Jérôme Lejeune

Registry information

Acronym: IMMUTRI

Important dates

Study start
2009
Study completion
2010
First posted
Dec 31, 2009
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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