Copy Number Variation in Prenatal Diagnosis

September 17, 2020 updated by: YiYang Zhu

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

16000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • total population need invasival prenatal diagnosis

Exclusion Criteria:

  • multipara

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
molecular karyotyping
Diagnostic test: molecular karyotyping
performed by NGS or CMA chip
cytogenic karyotyping
Diagnostic test: molecular karyotyping
performed by NGS or CMA chip

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YiYang Zhu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 19EZZDC7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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