NCT04561440

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

September 17, 2020

Last Update Submit

September 17, 2020

Conditions

Copy Number VariationGenome

Outcome Measures

Primary Outcomes (1)

  • comparison of CNVs distributions in subgroups

    subgroups including CNV-seq (by NGS) and CMA chip

    2016-2020

Secondary Outcomes (1)

  • comparison of CNVs distributions in demographic dates.

    2016-2020

Study Arms (2)

molecular karyotyping

Diagnostic Test: molecular karyotyping

cytogenic karyotyping

Diagnostic Test: molecular karyotyping

Interventions

molecular karyotypingDIAGNOSTIC_TEST

performed by NGS or CMA chip

cytogenic karyotypingmolecular karyotyping

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

total population need invasival prenatal diagnosis, which including total pregnant women whose aged over than 35 in Taizhou City of East China.

You may qualify if:

  • total population need invasival prenatal diagnosis

You may not qualify if:

  • multipara

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou Hospital of Zhejiang province

Taizhou, Zhejiang, 317000, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice dean of prenatal dignosis

Study Record Dates

First Submitted

September 17, 2020

First Posted

September 23, 2020

Study Start

December 1, 2016

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations

CN(1)