Pregnancy Clinical Trial
Official title:
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
| Verified date | February 2012 |
| Source | Sequenom, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.
| Status | Completed |
| Enrollment | 2502 |
| Est. completion date | December 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subject is female - Subject is pregnant - Subject is 18 years of age or older - Subject provides a signed and dated informed consent - Subject agrees to provide a 30-50mL blood sample - Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy). - Subject plans to undergo an amniocentesis and/or CVS procedure - Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided Exclusion Criteria: |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Universitaire de Nantes | Nantes | |
| France | Hopital Cochin Port Royal | Paris | |
| France | Hopital Robert Debre | Paris | |
| France | Hopital Paule de Viguier - CHU Toulouse | Toulouse | |
| France | Centre Hospitalier Regional et Universitaire - Hopital Bretonneau | Tours | |
| United States | Women's Clinic | Boise | Idaho |
| United States | Visions Clinical Research | Boynton Beach | Florida |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Reproductive Genetics Institute | Chicago | Illinois |
| United States | Complete Healthcare for Women | Columbus | Ohio |
| United States | Clinical Trials of America | Eugene | Oregon |
| United States | Spectrum Health - Maternal Fetal Medicine | Grand Rapids | Michigan |
| United States | Fetal Diagnostic Institution of the Pacific | Honolulu | Hawaii |
| United States | Houston Perinatal Associates | Houston | Texas |
| United States | Kingsport Perinatology | Kingsport | Tennessee |
| United States | Grossmont Center for Clinical Research | La Mesa | California |
| United States | South Florida Perinatal Medicine | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | University of South Alabama | Mobile | Alabama |
| United States | Perinatal Research Center | Nashville | Tennessee |
| United States | Tenessee Maternal Fetal Medicine | Nashville | Tennessee |
| United States | Methodist Hospital | Omaha | Nebraska |
| United States | Global Ob/Gyn Centers | Pembroke Pines | Florida |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | IGO | San Diego | California |
| United States | Poway Womens Care | San Diego | California |
| United States | San Diego Perinatal Center | San Diego | California |
| United States | Women's Healthcare at Frost Street | San Diego | California |
| United States | St Louis University | St Louis | Missouri |
| United States | Discovery Clinical Research | Sunrise | Florida |
| United States | Sheridan Clinical Research | Sunrise | Florida |
| United States | Lyndhurst Gynecologic Associates | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Sequenom, Inc. | PRA Health Sciences |
United States, France,
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