An interventional study of Cell-based non-invasive prenatal testing in Prenatal Screening, Pregnancy Related and Genetic Disease, sponsored by Menarini Biomarkers Singapore. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Menarini Biomarkers Singapore · Not applicable, Interventional, and Screening
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.
403 studies on the registry are indexed under Genetic Diseases, Inborn; 145 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 54 across 202 interventional studies indexed under Genetic Diseases, Inborn.
Browse Genetic Diseases, Inborn studies →This is the only study on the registry with Menarini Biomarkers Singapore as lead sponsor.
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Exclusion Criteria:
Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis
Other: Cell-based non-invasive prenatal testing
Blood sampling
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.
Time frame: 2 year
Number of suitable fetal cells
Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.
Time frame: 2 year
Fetal sex assessment
Early, non-invasive fetal sex assessment
Time frame: 2 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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