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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04561440
Other study ID # 19EZZDC7
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2016
Est. completion date December 30, 2020

Study information

Verified date September 2020
Source Taizhou Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16000
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- total population need invasival prenatal diagnosis

Exclusion Criteria:

- multipara

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
molecular karyotyping
performed by NGS or CMA chip

Locations

Country Name City State
China Taizhou Hospital of Zhejiang province Taizhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
YiYang Zhu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary comparison of CNVs distributions in subgroups subgroups including CNV-seq (by NGS) and CMA chip 2016-2020
Secondary comparison of CNVs distributions in demographic dates. demographic dates including indication of prenatal diagnosis 2016-2020
See also
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