Prenatal DiagnosisNCT03201666
Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies
An observational study of Prenatal Diagnosis, run by YiYang Zhu at 1 site in China.
Trial summary
This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prenatal Diagnosis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 31 Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant women who needed amniocenteses were recruited during the study period
Who may be able to join
- pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal.
- only singleton were included
Who cannot join
- women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease.
- Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Taizhou Hospital of Zhejiang province
Taizhou, Zhejiang, 317000
YiYang Zhu, MD, +8613819630569, zuyy@tzhospital.com
About this study
This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.
Read the detailed description
Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies.
Design: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited.
Methods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting.
Statistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.
- Conditions
- Prenatal Diagnosis
- Keywords
- prenatal diagnosis, non-invasive prenatal tests, chromosome microarray analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of NIPT for prenatal diagnosing chromosomal anomalies
sensitive, false negative rate, and false positive rate of NIPT compared with CMA
Measured: July,2016-July, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jul 2016
- Primary completion1 Jul 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal DiagnosisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YiYang Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiYang Zhu, Taizhou Hospital
- Investigators
- YiYang Zhu, MD, Study director, prenatal doagnosis center of taizhou city
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201666
- Sponsor's protocol ID
- TZ201607
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 29 Jun 2017
- 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 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies
- ClinicalTrials.gov ID
- NCT03201666
- Acronym / sponsor ID
- TZ201607
- Conditions
- Prenatal Diagnosis
- Keywords
- prenatal diagnosis, non-invasive prenatal tests, chromosome microarray analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- YiYang ZhuUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 28 Jun 2017 (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 diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.
Detailed description
Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies.
Design: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited.
Methods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting.
Statistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women who needed amniocenteses were recruited during the study period
Key inclusion criteria (2 listed)
- pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal.
- only singleton were included
Key exclusion criteria (2 listed)
- women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease.
- Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy of NIPT for prenatal diagnosing chromosomal anomalies
Time frame: July,2016-July, 2017
sensitive, false negative rate, and false positive rate of NIPT compared with CMA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- 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.
YiYang Zhu, MD study director
prenatal doagnosis center of taizhou city
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 Prenatal Diagnosis, run by YiYang Zhu at 1 site in China.
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 2 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 Jun 2017. 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 China. 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?
Contact YiYang Zhu, MD (+8613819630569, zuyy@tzhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of NIPT for prenatal diagnosing chromosomal anomalies (time frame: July,2016-July, 2017). 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 Jun 2017.