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| Name | Class |
|---|---|
| Brugmann University Hospital | OTHER |
| University of British Columbia | OTHER |
| Royal Prince Alfred Hospital, Sydney, Australia | OTHER |
| Hospital Universitario Virgen de la Arrixaca |
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The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| positive for fetal aneuploidy |
| ||
| negative for fetal aneuploidy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood test | Diagnostic Test | analysis of cell-free DNA in maternal plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of blood test to fetal karyotype | Maternal plasma cell-free DNA will be analyzed to determine copy number of specific chromosomes and compared to the fetal karyotype as obtained through invasive diagnostic testing of the fetus. | 21 months |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant with singleton or twin pregnancy and having and indicated physician prescribed prenatal diagnostic procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Musci, MD | BioCeryx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Sydney | Australia | ||||
| University Hospital Brugmann |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D014314 | Trisomy |
| D000782 | Aneuploidy |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| OTHER |
| Hospital CUF Descobertas, Lisbon, Portugal | UNKNOWN |
| University College London Hospitals | OTHER |
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| Brussels |
| Belgium |
| University of British Columbia | Vancouver | Canada |
| Hospital CUF Descobertas | Lisbon | Portugal |
| Hospital ClĂnico Universitario Virgen de la Arrixaca | Murcia | Spain |
| University College London Hospital | London | United Kingdom |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D058674 | Chromosome Duplication |