Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)

Trisomy 21 Clinical Trial

Official title:

Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03559374
• Other study ID #: F01-16013
• Status: Enrolling by invitation
• Start date: June 20, 2018
• Est. completion date: August 2020

Study information

• Verified date: August 2018
• Source: PerkinElmer, Wallac Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: August 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Trisomy 13
• Trisomy 18
• Trisomy 21

Intervention

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)

Locations

Country	Name	City	State
Italy	Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino	Turin

Sponsors (2)

Lead Sponsor	Collaborator
PerkinElmer, Wallac Oy	Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests		Three weeks
Secondary	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.	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.	Three weeks
Secondary	Evaluate preliminary cost effectiveness of Vanadis NIPT by evaluating resources, false positive rates and detection rates	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.	Three weeks
Secondary	Assess feasibility of Vanadis NIPT regarding determination of fetal sex by comparing the Vanadis NIPT result with the fetal karyotype from invasive testing		Three weeks