An observational study in Trisomy 21, Trisomy 18 and Trisomy 13, sponsored by PerkinElmer, Wallac Oy. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by PerkinElmer, Wallac Oy · Observational
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Among 14 studies in Down Syndrome with a site in Italy — 5 open to participants now, 5 under way, none of them phase 3. Down Syndrome · Italy.
Among the 14 studies in Down Syndrome with a site in Italy, this one is the only one that started in 2018, is one of 8 observational ones, and was the 7th registered.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
Browse Down Syndrome studies →5 of the 14 studies in Down Syndrome with a site in Italy are open now. Recruiting first, the newest first:
Aelis Farma · Sites in Italy, France, Spain
Ages 16–32
Floriana Costanzo · Sites in Italy
Ages 12–21
IRCCS San Raffaele Roma · Sites in Italy
Ages 4–18 · Healthy volunteers
Stefano Vicari · Sites in Italy
Ages 10–17
Colorado State University · Sites in Italy, United States
Ages 36 mo–72 mo
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.
This study: 18 Years to 55 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,200 is above the median of 158 across 145 observational studies indexed under Down Syndrome.
Median enrollment 107 across the 6 interventional studies, 1,822 across the 8 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 14 have an industry lead sponsor. The 10 most frequent:
PerkinElmer, Wallac Oy is the lead sponsor of 2 studies on the registry; none are open to participants now.
PerkinElmer, Wallac Oy has 1 study filed under Down Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Down Syndrome with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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Exclusion Criteria:
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)
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
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.
Time frame: 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.
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
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2018 (actual). Primary completion is estimated for Apr 2020, 22 months after the start.
Of 55 observational studies under Down Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 80. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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PerkinElmer, Wallac Oy