- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041469
Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome (IMMUTRI)
March 21, 2012 updated by: Institut Jerome Lejeune
The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75015
- Institut Jérôme Lejeune
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Paris, France, 75743
- Laboratoire d'Immunologie Biologique (Unité INSERM U580)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 36 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally retarded children and adults
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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with abnormalities
Down syndrome patients presenting with at least one sign of auto immune abnormality
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without abnormality
Down syndrome patients without any sign of recognized auto immune condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Auto-antibodies dosage
Time Frame: at enrolment
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at enrolment
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specific lymphocytes populations count
Time Frame: at enrolment
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at enrolment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 30, 2009
First Submitted That Met QC Criteria
December 30, 2009
First Posted (Estimate)
December 31, 2009
Study Record Updates
Last Update Posted (Estimate)
March 22, 2012
Last Update Submitted That Met QC Criteria
March 21, 2012
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IJL-IMM-EP10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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