Non-Invasive Screening for Fetal Aneuploidy: A New Matern... | NCT00770458

Studies
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

NCT00770458

Sponsor

Sequenom, Inc.

Status

Completed

Last Update Posted

Jan 6, 2010Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Down Syndrome (Trisomy 21)
Edwards Syndrome (Trisomy 18)
Patau Syndrome (Trisomy 13)
Turner Syndrome

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 2010

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

Jun 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Oct 8, 2008

First Submission Date that Met QC Criteria

Oct 9, 2008

First Posted Date

Oct 10, 2008Estimated

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 4, 2010

Last Update Posted Date

Jan 6, 2010Estimated

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

Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.

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

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women		Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare investigational assay results for Down Syndrome to standard of care results.		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is female
Subject is pregnant
Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
Subject is willing to provide blood specimen

Exclusion Criteria:

Subject is not pregnant
Subject is not willing to provide blood specimen
Subject is not haveing aneuploid screening

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

Fetal care and genetic counseling patients.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan Bombard, MD	Sequenom, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Fetal Care & Genetics Center		La Jolla	California	92037	United States
San Diego Perinatal Center

Condition Browse Module

MeSH Terms

ID	Term
D004314	Down Syndrome
D000073842	Trisomy 18 Syndrome
D000073839	Trisomy 13 Syndrome
D014424	Turner Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided