Clinical trial NCT03559374: Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)
Official title: Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trisomy 21
Trisomy 18
Trisomy 13
Keywords: Vanadis NIPT system
Lead sponsor: PerkinElmer, Wallac Oy
Sponsor class: INDUSTRY
Collaborators: name: A.O.U. Città della Salute e della Scienza
First posted: 2018-06-18
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Pregnant women attending the clinic for chorionic villus sampling or amniocentesis and have combined or integrated screening test result available
2. Pregnant women attending the clinic for chorionic villus sampling and willing to have combined or integrated screening test result for study purposes

Brief summary: This study will assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13. The results obtained from Vanadis NIPT will be compared with the study site's current prenatal screening methods. The primary objectives are: 1) To assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in the maternal healthcare setting, 2) To assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests, and 3) To evaluate preliminary cost effectiveness of Vanadis NIPT use in different models. The secondary objective is to assess the feasibility of Vanadis NIPT regarding determination of fetal sex.


Eligibility criteria: Inclusion Criteria:

* between the age of 18 and 55 years (inclusive)
* ≥ 10+0 weeks gestation

Exclusion Criteria:

* Pregnant woman undergoing amniocentesis without any screening test result
* Pregnant woman with previous severe hypotension episodes or other conditions that may complicate the blood sampling
* Known maternal aneuploidy
* Known maternal cancer
* Invasive test (chorionic villus sampling or amniocentesis) performed before blood sampling for NIPT

Primary outcomes:
measure: Assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests
timeFrame: Three weeks
Secondary outcomes:
measure: 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.
timeFrame: Three weeks
measure: Evaluate preliminary cost effectiveness of Vanadis NIPT by evaluating resources, false positive rates and detection rates
timeFrame: Three weeks
measure: Assess feasibility of Vanadis NIPT regarding determination of fetal sex by comparing the Vanadis NIPT result with the fetal karyotype from invasive testing
timeFrame: Three weeks
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino
Study officials:
affiliation: Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino
name: Enza Pavanello
role: PRINCIPAL_INVESTIGATOR
References: