Noninvasive Prenatal Diagnosis: Using Fetal Cells From Maternal Blood
National Institute of Child Health and Human Development Fetal Cell Isolation Study (NIFTY)
5 other identifiers
observational
3,500
1 country
5
Brief Summary
This purpose of this study is to develop noninvasive methods of prenatal diagnosis. Fetal cells can be found in maternal blood. This study is designed to isolate these fetal cells from a sample of the pregnant woman's blood and use those cells to test for fetal chromosome abnormalities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 1987
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1987
CompletedFirst Submitted
Initial submission to the registry
July 10, 2003
CompletedFirst Posted
Study publicly available on registry
July 11, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedJune 24, 2005
June 1, 2003
July 10, 2003
June 23, 2005
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Pregnant
- Abnormal serum marker profile (alpha-fetoprotein, hCG, estriol)
- Ultrasound abnormalities of the fetus
- Any high risk indicator for aneuploidy as determined by physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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, 19107-5563, United States
Baylor College of Medicine
Houston, Texas, United States
Related Publications (5)
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.
PMID: 12531583BACKGROUNDBianchi 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.
PMID: 12124698BACKGROUNDBianchi 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.
PMID: 11978594BACKGROUNDBohmer 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.
PMID: 11844911BACKGROUNDLee 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.
PMID: 12439507BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laird Jackson, MD
- PRINCIPAL INVESTIGATOR
Diana Bianchi, MD
- PRINCIPAL INVESTIGATOR
Mark Evans, MD
- PRINCIPAL INVESTIGATOR
Sherman Elias, MD
Study Design
- Study Type
- observational
- Observational Model
- DEFINED POPULATION
- Time Perspective
- OTHER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 10, 2003
First Posted
July 11, 2003
Study Start
December 1, 1987
Study Completion
December 1, 2003
Last Updated
June 24, 2005
Record last verified: 2003-06