MatErnal BLood IS Source to Accurately Diagnose Fetal Ane... | NCT01122524

Studies
MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

NCT01122524

Sponsor

Verinata Health, Inc.

Status

Completed

Last Update Posted

Oct 10, 2011Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Pregnant Women
Prenatal Care

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

Oct 2011

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 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

May 11, 2010

First Submission Date that Met QC Criteria

May 11, 2010

First Posted Date

May 13, 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

Oct 6, 2011

Last Update Posted Date

Oct 10, 2011Estimated

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 primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).

Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.

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

Not provided

Description

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chromosomal Abnormality		Fetus affected by chromosomal abnormality
No Chromosomal Abnormality		Fetus not affected by chromosomal abnormality

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.		10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Clinically confirmed viable pregnancy at the time of enrollment
Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
Able to provide consent for participation using language appropriate forms and consent process

Exclusion Criteria:

- Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

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 undergoing chorionic villus sampling (CVS) or amniocentesis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy J Sehnert, MD	Verinata Health, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Fetal Medicine		Los Angeles	California	90048	United States
San Francisco Perinatal Associates

References Module

Citations

PubMed Identifier	Type	Citation
	Background	http://www.clinchem.org/cgi/content/abstract/clinchem.2011.165910
23635743	Derived	Bianchi DW, Prosen T, Platt LD, Goldberg JD, Abuhamad AZ, Rava RP, Sehnert AJ; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group*. Massively parallel sequencing of maternal plasma DNA in 113 cases of fetal nuchal cystic hygroma. Obstet Gynecol. 2013 May;121(5):1057-1062. doi: 10.1097/AOG.0b013e31828ba3d8.
22362253

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