Noninvasive Prenatal Diagnosis: Using Fetal Cells From Maternal Blood
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00064597|
Recruitment Status : Unknown
Verified June 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Active, not recruiting
First Posted : July 11, 2003
Last Update Posted : June 24, 2005
|Condition or disease|
Fetal cells can be recovered from maternal blood, suggesting that noninvasive prenatal diagnosis is possible. However, recovery and analysis of fetal cells from maternal blood is complex and sensitivity is low because of the rarity of these cells in the maternal circulation. This study was designed to develop a noninvasive, safe, relatively inexpensive, and accurate technique for the prenatal diagnosis of genetic disorders in the first trimester.
The study included a systematic evaluation of variables involved in separating and enriching fetal cells isolated from maternal blood through fluorescence activated cell sorting (FACS) and magnetic activated cell sorting (MACS) followed by fluorescent in situ hybridization (FISH) with chromosome-specific DNA probes. The results of these tests were compared to those obtained from amniocentesis or chorionic villus sampling (CVS) on the same women. No clinical decision was made based on the results of the experimental diagnostic/screening technique.
Even if the biological risks associated with reproductive genetic technologies are reduced, it is possible that other risks (or benefits) are associated with the procedures. Some of these factors may be: increased or diminished maternal anxiety, increased adjustment or maladaption to the pregnancy, increased feelings of coercion to undertake the procedure, and increased or decreased comfort with reproductive decision-making. The study also assessed whether there were any nonbiological or psychological effects on the women undergoing prenatal diagnostic testing.
After the first five years of the study, preliminary analysis of the data showed that the sensitivity of aneuploidy detection using fetal cell analysis from maternal blood is comparable to single marker prenatal serum screening, but technological advances are needed before fetal cell analysis has clinical application as part of a multiple maker method for noninvasive prenatal screening. Target cell recovery and fetal cell detection were better using MACS than with FACS. The detection rate of finding at least one aneuploid cell in cases of fetal aneuploidy was 74.4%.
|Study Type :||Observational|
|Enrollment :||3500 participants|
|Observational Model:||Defined Population|
|Official Title:||National Institute of Child Health and Human Development Fetal Cell Isolation Study (NIFTY)|
|Study Start Date :||December 1987|
|Study Completion Date :||December 2003|
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): NCT00064597
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States|
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States|
|United States, Pennsylvania|
|Jefferson Medical College|
|Philadelphia, Pennsylvania, United States, 19107-5563|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States|
|Principal Investigator:||Laird Jackson, MD|
|Principal Investigator:||Diana Bianchi, MD|
|Principal Investigator:||Mark Evans, MD|
|Principal Investigator:||Sherman Elias, MD|