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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
Sponsor:
Collaborator:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Information provided by (Responsible Party):
PerkinElmer, Wallac Oy

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.

Condition or disease Intervention/treatment
Trisomy 21 Trisomy 18 Trisomy 13 Other: Vanadis NIPT system

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Pregnant women
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)




Primary Outcome Measures :
  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 [ Time Frame: Three weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

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


Locations
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Italy
Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino
Turin, Italy
Sponsors and Collaborators
PerkinElmer, Wallac Oy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Investigators
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Principal Investigator: Enza Pavanello Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino

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Responsible Party: PerkinElmer, Wallac Oy
ClinicalTrials.gov Identifier: NCT03559374     History of Changes
Other Study ID Numbers: F01-16013
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PerkinElmer, Wallac Oy:
Vanadis NIPT system

Additional relevant MeSH terms:
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Trisomy 13 Syndrome
Trisomy
Down Syndrome
Trisomy 18 Syndrome
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases