Trial record 18 of 23 for: "trisomy 18"

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Comparison of Aneuploidy Risk Evaluations (CARE)

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ClinicalTrials.gov Identifier: NCT01663350

Recruitment Status : Completed

First Posted : August 13, 2012

Last Update Posted : July 16, 2013

Sponsor:

Information provided by (Responsible Party):

Verinata Health, Inc.

Study Description

Brief Summary:

This is a prospective, multi‐center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.

Condition or disease
Pregnancy Down Syndrome Edwards Syndrome Patau Syndrome Turners Syndrome

Study Design


Study Type :	Observational
Estimated Enrollment :	3000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All‐Risk' Population
Study Start Date :	July 2012
Actual Primary Completion Date :	July 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Down syndrome Turner syndrome Trisomy 13 Trisomy 18

Genetic and Rare Diseases Information Center resources: Turner Syndrome Gonadal Dysgenesis Trisomy 18 Trisomy 13

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
All-risk pregnant women All-risk pregnancies undergoing conventional forms of prenatal screening

Outcome Measures

Primary Outcome Measures :

Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). [ Time Frame: 12 months ]
The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.

Biospecimen Retention: Samples With DNA

Plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population is comprised of pregnant women at least 18 years of age, who meet the study eligibility criteria. Women who plan or have already completed prenatal screening for fetal aneuploidy during first and/or second trimester, will be recruited from approved participating clinical centers.

Criteria

Inclusion Criteria:

Age 18 years or older at enrollment
Clinically confirmed pregnancy
Gestational age ≥8 weeks, 0 days
Planned or completed prenatal serum screening* (drawn during 1st and/or 2nd trimester)
Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam)
Able to provide consent for participation using language appropriate forms

Exclusion Criteria:

Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
Prenatal screening determination by Nuchal Translucency (NT) measurement only

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663350

Show 26 Study Locations

Sponsors and Collaborators

Verinata Health, Inc.

Investigators


Study Director:	Amy J Sehnert, MD	Verinata Health, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.


Responsible Party:	Verinata Health, Inc.
ClinicalTrials.gov Identifier:	NCT01663350 History of Changes
Other Study ID Numbers:	VER-0007
First Posted:	August 13, 2012 Key Record Dates
Last Update Posted:	July 16, 2013
Last Verified:	July 2013

Additional relevant MeSH terms:


Syndrome Down Syndrome Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Aneuploidy Disease Pathologic Processes Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders	Genetic Diseases, Inborn Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Sex Chromosome Disorders Gonadal Disorders Endocrine System Diseases Ovarian Diseases Adnexal Diseases Genital Diseases, Female Chromosome Aberrations

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