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The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood samples from pregnant women | Other | Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell-based non-invasive prenatal testing | Other | Blood sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal chromosomal abnormalities detection in circulating fetal cells, | Evaluation of clinical performance of a cell-based technology for fetal chromosomal abnormalities detection in circulating fetal cells, using maternal blood samples from a population of high-risk pregnancies undergoing clinically indicated fetal diagnostic procedures. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of suitable fetal cells | Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis. | 2 year |
| Fetal sex assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Bolognesi | Contact | +39 051 9944165 | cbolognesi@siliconbiosystems.com | |
| Anna Doffini | Contact | +39 051 9944253 | anna.doffini@mbiomarkers.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore | Recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Early, non-invasive fetal sex assessment
| 2 year |