Copy Number VariationNCT04561440
Copy Number Variation in Prenatal Diagnosis
An observational study of Copy Number Variation and Genome, run by YiYang Zhu at 1 site in China.
Trial summary
An observed study is aim to map the CNVs distribution in human genome of Chinese prenatal population. Setting: Prenatal diagnosis center of Taizhou City, Zhejiang Province Patient: total cases of pregnant women needed prenatal genetic diagnosing Methods: karyotype was performed with combined of molecular and cytogenic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Copy Number Variation, Genome
- What is being tested?
- molecular karyotyping
- How many people
- 16,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 30 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: total population need invasival prenatal diagnosis, which including total pregnant women whose aged over than 35 in Taizhou City of East China.
Who may be able to join
- total population need invasival prenatal diagnosis
Who cannot join
- multipara
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
An observed study is aim to map the CNVs distribution in human genome of Chinese prenatal population.
Setting: Prenatal diagnosis center of Taizhou City, Zhejiang Province Patient: total cases of pregnant women needed prenatal genetic diagnosing Methods: karyotype was performed with combined of molecular and cytogenic protocol. Subgroup: molecular karyotyping performed by genomic Chip (CMA) or NGS, the latter including cnv-seq and NIPT.
Main outcome: comparison of CNVs distributions in subgroups. Second outcome: comparison of CNVs distributions in demographic dates.
- Conditions
- Copy Number Variation, Genome
- Being tested
- molecular karyotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular karyotypingDiagnostic test
performed by NGS or CMA chip
| Study group | Role | What they receive |
|---|---|---|
| molecular karyotyping | Not described Receives: Diagnostic Test: molecular karyotyping | |
| cytogenic karyotyping | Not described Receives: Diagnostic Test: molecular karyotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of CNVs distributions in subgroups
subgroups including CNV-seq (by NGS) and CMA chip
Measured: 2016-2020
Secondary outcomes (1)
comparison of CNVs distributions in demographic dates.
demographic dates including indication of prenatal diagnosis
Measured: 2016-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Dec 2016
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Copy Number VariationStudies 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
- Retrospective
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YiYang Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiYang Zhu, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561440
- Sponsor's protocol ID
- 19EZZDC7
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copy Number Variation in Prenatal Diagnosis
- ClinicalTrials.gov ID
- NCT04561440
- Acronym / sponsor ID
- 19EZZDC7
- Conditions
- Copy Number Variation, Genome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- YiYang ZhuUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 23 Sep 2020 (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.
An observed study is aim to map the CNVs distribution in human genome of Chinese prenatal population.
Setting: Prenatal diagnosis center of Taizhou City, Zhejiang Province Patient: total cases of pregnant women needed prenatal genetic diagnosing Methods: karyotype was performed with combined of molecular and cytogenic protocol. Subgroup: molecular karyotyping performed by genomic Chip (CMA) or NGS, the latter including cnv-seq and NIPT.
Main outcome: comparison of CNVs distributions in subgroups. Second outcome: comparison of CNVs distributions in demographic dates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| molecular karyotyping | – | Diagnostic Test: molecular karyotyping |
| cytogenic karyotyping | – | Diagnostic Test: molecular karyotyping |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- total population need invasival prenatal diagnosis, which including total pregnant women whose aged over than 35 in Taizhou City of East China.
Key inclusion criteria (1 listed)
- total population need invasival prenatal diagnosis
Key exclusion criteria (1 listed)
- multipara
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 |
|---|---|---|
| molecular karyotypingperformed by NGS or CMA chip | Diagnostic test | cytogenic karyotyping, molecular karyotyping |
Primary outcome
comparison of CNVs distributions in subgroups
Time frame: 2016-2020
subgroups including CNV-seq (by NGS) and CMA chip
1 secondary outcome
comparison of CNVs distributions in demographic dates.
Time frame: 2016-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Copy Number Variation and Genome, 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 1 inclusion and 1 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 23 Sep 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of CNVs distributions in subgroups (time frame: 2016-2020). 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 23 Sep 2020.