Trisomy 21NCT03559374
Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)
An observational study of Trisomy 21 and Trisomy 18, run by PerkinElmer, Wallac Oy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Trisomy 21, Trisomy 18, Trisomy 13
- What is being tested?
- Vanadis NIPT system
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2018to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- between the age of 18 and 55 years (inclusive)
- ≥ 10+0 weeks gestation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino
Turin
About this study
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
- Being tested
- Vanadis NIPT system
- Keywords
- Vanadis NIPT system
- Medical subject headings
- Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanadis NIPT systemOther
A novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing)
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Consenting women will provide samples to be tested with Vanadis NIPT system. Receives: Other: Vanadis NIPT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests
Measured: 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.
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.
Measured: Three weeks
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.
Measured: 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
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start20 Jun 2018
- Primary completionApr 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trisomy 21Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PerkinElmer, Wallac Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- A.O.U. Città della Salute e della Scienza
- Responsible party
- Sponsor
- Investigators
- Enza Pavanello, Principal investigator, Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559374
- Sponsor's protocol ID
- F01-16013
- Status last verified
- Aug 2018
- First submitted
- 17 May 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)
- ClinicalTrials.gov ID
- NCT03559374
- Acronym / sponsor ID
- F01-16013
- Conditions
- Trisomy 21, Trisomy 18, Trisomy 13
- Keywords
- Vanadis NIPT system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- PerkinElmer, Wallac OyIndustry (pharma, biotech, devices)
- Collaborators
- A.O.U. Città della Salute e della Scienza
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Vanadis NIPT systemConsenting women will provide samples to be tested with Vanadis NIPT system. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- between the age of 18 and 55 years (inclusive)
- ≥ 10+0 weeks gestation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vanadis NIPT systemA novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing) | Other | Pregnant women |
Primary outcome
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
3 secondary outcomes
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
Evaluate preliminary cost effectiveness of Vanadis NIPT by evaluating resources, false positive rates and detection rates
Time frame: 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
Time frame: Three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enza Pavanello principal investigator
Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trisomy 21 and Trisomy 18, run by PerkinElmer, Wallac Oy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.