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

NCT03559374 | Unknown

• 1 other identifier: F01-16013
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Trisomy 21; Trisomy 18; Trisomy 13

Keywords

Vanadis NIPT system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  Three weeks

• Evaluate preliminary cost effectiveness of Vanadis NIPT by evaluating resources, false positive rates and detection rates

  Three weeks

• 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

Study Arms (1)

Pregnant women

Consenting women will provide samples to be tested with Vanadis NIPT system.

Other: Vanadis NIPT system

Interventions

Vanadis NIPT system OTHER

A novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing)

Pregnant women

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• PerkinElmer, Wallac Oy: lead
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (1)

Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino

Turin, Italy

Location

MeSH Terms

Conditions

Down Syndrome; Trisomy 18 Syndrome; Trisomy 13 Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Study Officials

• Enza Pavanello

  Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 18, 2018
• Study Start: June 20, 2018
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)