Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood

NACompletedINTERVENTIONAL
Enrollment

3,819

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Trisomy 21Trisomy 18Trisomy 13
Interventions
OTHER

Integrated prenatal screening for Down's syndrome

Analysis of several serum biochemical markers, and fetal nuchal translucency by ultrasound, with computation of an individual risk of fetal aneuploidy.

OTHER

Serum QUAD Assay for aneuploidy screening

Series of biochemical markers with results integrated into a computational estimate of risk of fetal aneuploidy

OTHER

Semiconductor MPSS NIPT assay using ccfDNA in maternal blood

Analysis by next-generation sequencing of ccfDNA (circulating cell-free DNA) from maternal blood, using a targeted NIPT assay.

OTHER

Optical-based MPSS NIPT assay using ccfDNA in maternal blood

Analysis by next-generation sequencing of ccfDNA (circulating cell-free DNA) from maternal blood, using an un-targeted NIPT assay.

OTHER

Harmony™ Test (Ariosa Diagnostics)

Test that is commercially available (Ariosa Diagnostics). (will be used for benchmarking purposes in a subset of each arm)

Trial Locations (5)

T2N 2T9

Foothills Medical Centre, Calgary

V6H 3N1

Children's & Women's Health Centre, Vancouver

K1H 8L6

The Ottawa Hospital, Ottawa

H3T 1C5

CHU Ste-Justine, Montreal

G1L3L5

CHU de Québec, Québec

All Listed Sponsors
collaborator

Laval University

OTHER

collaborator

Genome Canada

OTHER

collaborator

Genome Quebec

OTHER

collaborator

Genome British Columbia

INDUSTRY

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

CHU de Quebec-Universite Laval

OTHER

NCT01925742 - Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood | Biotech Hunter | Biotech Hunter