Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064597
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-07-10
Brief Title:
Noninvasive Prenatal Diagnosis Using Fetal Cells From Maternal Blood
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
National Institute of Child Health and Human Development Fetal Cell Isolation Study NIFTY
Status:
UNKNOWN
Status Verified Date:
2003-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans blood and use those cells to test for fetal chromosome abnormalities
Detailed Description:
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 diagnosticscreening 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 744
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 diagnosticscreening 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 744
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1N01HD43204 | None | None | None |
| 1N01HD43201 | None | None | None |
| 1N01HD43202 | None | None | None |
| 1N01HD43203 | None | None | None |