Copy Number Variation in Prenatal Diagnosis | NCT04561440

Studies
Copy Number Variation in Prenatal Diagnosis

NCT04561440

Sponsor

YiYang Zhu

Status

Unknown status

Last Update Posted

Sep 23, 2020Actual

Enrollment

16,000Estimated

Phase

Not provided

Conditions

Copy Number Variation
Genome

Interventions

molecular karyotyping

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Sep 17, 2020

First Submission Date that Met QC Criteria

Sep 17, 2020

First Posted Date

Sep 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2020

Last Update Posted Date

Sep 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
molecular karyotyping			Diagnostic Test: molecular karyotyping
cytogenic karyotyping			Diagnostic Test: molecular karyotyping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
molecular karyotyping	Diagnostic Test	performed by NGS or CMA chip	cytogenic karyotyping molecular karyotyping

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
comparison of CNVs distributions in subgroups	subgroups including CNV-seq (by NGS) and CMA chip	2016-2020

Secondary Outcomes

Measure	Description	Time Frame
comparison of CNVs distributions in demographic dates.	demographic dates including indication of prenatal diagnosis	2016-2020

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

total population need invasival prenatal diagnosis

Exclusion Criteria:

multipara

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taizhou Hospital of Zhejiang province	Recruiting	Taizhou	Zhejiang	317000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided