Correlations Phenotype / Genotype in Down Syndrome (INTREPID)
This study has been completed.
Sponsor:
Institut Jerome Lejeune
Collaborator:
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune
ClinicalTrials.gov Identifier:
NCT01034280
First received: December 16, 2009
Last updated: March 21, 2012
Last verified: December 2009
| Tracking Information | |||||
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| First Received Date ICMJE | December 16, 2009 | ||||
| Last Updated Date | March 21, 2012 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01034280 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Correlations Phenotype / Genotype in Down Syndrome | ||||
| Official Title ICMJE | Epidemiological Study of Trisomy 21 With Research of Correlations Between Phenotype (Physical, Psychometrical) and Genotype (Genome, Transcriptome, Proteome) | ||||
| Brief Summary | The purpose of this study is to correlate phenotype and genotype of Down syndrome patients in order to identify the biochemical reactions involved in their mental retardation and their other phenotypic characteristics. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Down syndrome patients |
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| Condition ICMJE | Down Syndrome | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 524 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01034280 | ||||
| Other Study ID Numbers ICMJE | IJL-PG-EP03, Intrepid | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Institut Jerome Lejeune | ||||
| Study Sponsor ICMJE | Institut Jerome Lejeune | ||||
| Collaborators ICMJE | Fondation Jérôme Lejeune | ||||
| Investigators ICMJE |
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| Information Provided By | Institut Jerome Lejeune | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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