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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01118507 |
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Date of registration:
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28/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trisomy of Chromosome 21 Diagnosis by High Output Sequencing
SEQ21 |
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Scientific title:
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Trisomy of Chromosome 21 Diagnosis by High Output Sequencing of Foetal Circulating DNA in Mother Blood at First Trimester of Pregnancy. |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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976 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01118507 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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LAURENT SALOMON, MCU PH |
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Address:
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Telephone:
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Email:
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Affiliation:
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APHP |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 years,
- patient coming from one of multidisciplinary prenatal diagnosis center
- having à high risk of trisomy of chromosome 21 estimated by combine screening > 1/250
- 11 weeks of gestation or high
- accepting invasive prenatal diagnosis of chromosomal abnormalities
- accepting genetic analysis of blood circulating DNA
- Patient accepting to sign the enlightened assent
Exclusion Criteria:
- Patient of less than 18 years
- combine risk < 1/250
- refusing invasive prenatal diagnosis of chromosomal abnormalities
- refusing genetic analysis of blood circulating DNA
- Patient refusing to sign the enlightened assent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Trisomy 21 - Translocation
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Primary Outcome(s)
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The diagnostic performances of the quantification of the DNA resulting from the chromosome 21 by High output shotgun sequencing
[Time Frame: 24 MONTHS]
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Secondary Outcome(s)
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The cost by taking.
[Time Frame: 24 MONTHS]
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The time necessary for the treatments of samples:
[Time Frame: 24 MONTHS]
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The repeatability of the quantification:
[Time Frame: 24 MONTHS]
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Secondary ID(s)
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2009-A00908-49
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AOM 09071
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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