Development of a Prenatal Test for Fetal Aneuploidy Detec... | NCT01451671

Studies
Development of a Prenatal Test for Fetal Aneuploidy Detection

NCT01451671

Sponsor

Cindy Cisneros

Status

Completed

Last Update Posted

Apr 30, 2020Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Fetal Complications

Interventions

Not provided

Countries

United States

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2019Actual

Completion Date

Nov 2019Actual

First Submitted Date

Oct 10, 2011

First Submission Date that Met QC Criteria

Oct 13, 2011

First Posted Date

Oct 14, 2011Estimated

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

Apr 28, 2020

Last Update Posted Date

Apr 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

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

Not provided

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

1,500Actual

Measure	Description	Time Frame
Identification of aneuploidy		At enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has singleton pregnancy
Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
Subject is able to provide informed consent
Subject is ≥ 18 years of age

Exclusion Criteria:

Subject is pregnant with more than one fetus
Subject (mother) has a known aneuploidy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tracy Roberts	Ariosa Diagnostics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego		San Diego	California	92037	United States
Norton Healthcare

Condition Browse Module

MeSH Terms

ID	Term
D000782	Aneuploidy

Ancestor Terms

ID	Term
D002869	Chromosome Aberrations
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided