Copy Number Variation in Prenatal Diagnosis

Copy Number Variation Clinical Trial

Official title:

Copy Number Variation in Prenatal Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561440
• Other study ID #: 19EZZDC7
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Copy Number Variation
• Genome

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