Prenatal Test for Fetal Aneuploidy Detection | NCT01256606

Studies
Prenatal Test for Fetal Aneuploidy Detection

NCT01256606

Sponsor

Roche Sequencing Solutions

Status

Completed

Last Update Posted

Jan 10, 2013Estimated

Enrollment

4,000Actual

Phase

Not provided

Conditions

Aneuploidy
Trisomy 21

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

Jan 2013

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

Aug 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Nov 22, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 8, 2010Estimated

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

Jan 8, 2013

Last Update Posted Date

Jan 10, 2013Estimated

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

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

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

4,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection	Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18yrs or older
Subject has a singleton pregnancy
Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
Subject is able to provide consent

Exclusion Criteria:

Subject is pregnant with more than one fetus
Subject (mother) has known aneuploidy
Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ken Song, MD	Ariosa Diagnostics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
East Bay Perinatal Medical Associates		Oakland	California	94609	United States
Prenatal Diagnosis of Northern California

Condition Browse Module

MeSH Terms

ID	Term
D000782	Aneuploidy
D004314	Down Syndrome

Ancestor Terms

ID	Term
D002869	Chromosome Aberrations
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008607	Intellectual Disability

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Positive for fetal aneuploidy
Negative for fetal aneuploidy