Cell-based Non-invasive Prenatal Testing as an Alternative to Invasive Chorionic Villus Sampling
NCT ID: NCT05453474
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2021-08-08
2023-06-27
Brief Summary
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Detailed Description
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1. to evaluate the optimal time of blood sampling (gestational week 7-8 or 11-14)
2. to evaluate whole genome amplification prior to genetic analysis og isolated fetal cells (only relevant for monogenic disorders)
3. evaluating specificity and sensitivity
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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WGA
DNA from the cells are amplified by whole genome amplification prior to genetic testing.
Whole genome amplification
DNA is amplified by whole genome amplification
No-WGA
DNA from the cells are tested directly without whole genome amplification
No interventions assigned to this group
Interventions
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Whole genome amplification
DNA is amplified by whole genome amplification
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Arcedi Biotech
INDUSTRY
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Responsible Party
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Christian Liebst Frisk Toft
Principal investigator, Molecular Biologist, ph.d.
Locations
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Fertility Unit, Aalborg University Hospital
Aalborg, , Denmark
Countries
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References
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Toft CLF, Ingerslev HJ, Kesmodel US, Hatt L, Singh R, Ravn K, Nicolaisen BH, Christensen IB, Kolvraa M, Jeppesen LD, Schelde P, Vogel I, Uldbjerg N, Farlie R, Sommer S, Ostergard MLV, Jensen AN, Mogensen H, Kjartansdottir KR, Degn B, Okkels H, Ernst A, Pedersen IS. Cell-based non-invasive prenatal testing for monogenic disorders: confirmation of unaffected fetuses following preimplantation genetic testing. J Assist Reprod Genet. 2021 Aug;38(8):1959-1970. doi: 10.1007/s10815-021-02104-5. Epub 2021 Mar 7.
Related Links
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ARCEDI Biotech homepage
Other Identifiers
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N-20180001 (cbNIPT v2)
Identifier Type: -
Identifier Source: org_study_id
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