Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)
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|ClinicalTrials.gov Identifier: NCT03559374|
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2018
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment|
|Trisomy 21 Trisomy 18 Trisomy 13||Other: Vanadis NIPT system|
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||August 2020|
Consenting women will provide samples to be tested with Vanadis NIPT system.
Other: Vanadis NIPT system
A novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing)
- Assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests [ Time Frame: Three weeks ]
- Assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in comparison to fetal karyotype from invasive testing, and by evaluating overall usability of the test in routine laboratory work. [ Time Frame: Three weeks ]Evaluation includes the follow up for each woman and matching the results of combined and integrated test and with the results of NIPT and karyotype. Feasibility will be assessed by determining the concordance between chromosomal abnormalities determined by Vanadis NIPT and trisomies confirmed by karyotype analysis, and by assessing the overall usability in the public healthcare setting by evaluating e.g. turnaround time and user friendliness.
- Evaluate preliminary cost effectiveness of Vanadis NIPT by evaluating resources, false positive rates and detection rates [ Time Frame: Three weeks ]Cost effectiveness will be evaluated when the test is offered to all women or only women with T21 risk between 1:100 and 1:2500 or between 1:11 and 1:1000, or alternatively to 3000 or 10000 women annually. Cost effectiveness will be assessed by taking into account the costs of NIPT, combined test, invasive procedure, fetal karyotype and counselling, the potential benefits (rate of reduction of invasive procedures, miscarriages, births with trisomy 21) and births with chromosomal diseases undetectable with NIPT.
- Assess feasibility of Vanadis NIPT regarding determination of fetal sex by comparing the Vanadis NIPT result with the fetal karyotype from invasive testing [ Time Frame: Three weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559374
|Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino|
|Principal Investigator:||Enza Pavanello||Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino|