Noninvasive Prenatal Diagnosis: Using Fetal Cells From Maternal Blood
NCT ID: NCT00064597
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3500 participants
OBSERVATIONAL
1987-12-31
2003-12-31
Brief Summary
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Detailed Description
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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%.
Conditions
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Keywords
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Study Design
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DEFINED_POPULATION
OTHER
Eligibility Criteria
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Inclusion Criteria
* Abnormal serum marker profile (alpha-fetoprotein, hCG, estriol)
* Ultrasound abnormalities of the fetus
* Any high risk indicator for aneuploidy as determined by physician
16 Years
45 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Laird Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Diana Bianchi, MD
Role: PRINCIPAL_INVESTIGATOR
Mark Evans, MD
Role: PRINCIPAL_INVESTIGATOR
Sherman Elias, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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University of Illinois at Chicago
Chicago, Illinois, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Jefferson Medical College
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Bischoff FZ, Hahn S, Johnson KL, Simpson JL, Bianchi DW, Lewis DE, Weber WD, Klinger K, Elias S, Jackson LG, Evans MI, Holzgreve W, de la Cruz F. Intact fetal cells in maternal plasma: are they really there? Lancet. 2003 Jan 11;361(9352):139-40. doi: 10.1016/S0140-6736(03)12191-5.
Bianchi DW, Simpson JL, Jackson LG, Elias S, Holzgreve W, Evans MI, Dukes KA, Sullivan LM, Klinger KW, Bischoff FZ, Hahn S, Johnson KL, Lewis D, Wapner RJ, de la Cruz F. Fetal gender and aneuploidy detection using fetal cells in maternal blood: analysis of NIFTY I data. National Institute of Child Health and Development Fetal Cell Isolation Study. Prenat Diagn. 2002 Jul;22(7):609-15. doi: 10.1002/pd.347.
Bianchi DW. Prenatal exclusion of recessively inherited disorders: should maternal plasma analysis precede invasive techniques? Clin Chem. 2002 May;48(5):689-90. No abstract available.
Bohmer RM, Stroh HP, Johnson KL, LeShane ES, Bianchi DW. Fetal cell isolation from maternal blood cultures by flow cytometric hemoglobin profiles. Results of a preliminary clinical trial. Fetal Diagn Ther. 2002 Mar-Apr;17(2):83-9. doi: 10.1159/000048014.
Lee T, LeShane ES, Messerlian GM, Canick JA, Farina A, Heber WW, Bianchi DW. Down syndrome and cell-free fetal DNA in archived maternal serum. Am J Obstet Gynecol. 2002 Nov;187(5):1217-21. doi: 10.1067/mob.2002.127462.
Other Identifiers
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1N01HD43201
Identifier Type: -
Identifier Source: secondary_id
1N01HD43202
Identifier Type: -
Identifier Source: secondary_id
1N01HD43203
Identifier Type: -
Identifier Source: secondary_id
1N01HD43204
Identifier Type: -
Identifier Source: secondary_id
NICHD-NIFTY
Identifier Type: -
Identifier Source: org_study_id