Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
This study has been completed.
Information provided by (Responsible Party):
First received: September 1, 2009
Last updated: February 15, 2012
Last verified: February 2012
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.
||Time Perspective: Prospective
||Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Biospecimen Retention: Samples With DNA
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Pregnant women who are scheduled to undergo a CVS or amniocentesis procedure and will receive the FISH, karyotype and/or QF-PCR results from the procedure.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971334
||Allan T Bombard, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2009
||February 15, 2012
||United States: Institutional Review Board
Keywords provided by Sequenom, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Nervous System Diseases
Genetic Diseases, Inborn