Prenatal Test for Fetal Aneuploidy Detection

NCT01256606 | Completed

• 1 other identifier: TT001
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Aneuploidy; Trisomy 21

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Positive for fetal aneuploidy

Negative for fetal aneuploidy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roche Sequencing Solutions: lead

Study Sites (6)

East Bay Perinatal Medical Associates

Oakland, California, 94609, United States

Location

Prenatal Diagnosis of Northern California

Sacramento, California, 95815, United States

Location

University of California - San Diego

San Diego, California, 92121, United States

Location

University of California - San Francisco

San Francisco, California, 94122, United States

Location

Atlanta Perinatal Consultants

Atlanta, Georgia, 30342, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Aneuploidy; Down Syndrome

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Ken Song, MD

  Ariosa Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 8, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (6)