Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02787486
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2016-05-26
Brief Title:
Expanded Noninvasive Genomic Medical Assessment The Enigma Study
Sponsor:
Progenity Inc
Organization:
Progenity Inc
Study Overview
Official Title:
A Clinical Study to Evaluate the Relative Clinical Sensitivity Specificity and Performance of the a Laboratory Developed Test as a Screening Test for Fetal Chromosomal Aneuploidy Infectious and Other Diseases and RhD Genotyping in the General Population of Pregnant Women
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
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:
In January 2007 the American Congress of Obstetricians and Gynecologists ACOG revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal abnormalities including biochemical screening tests and invasive procedures such as CVS or amniocentesis is available regardless of age Further it is entirely up to the patient to decide whether or not she wishes to be screened for fetal chromosomal abnormalities without judgment from the physician
Noninvasive laboratory-developed tests LDTs that detect an abnormal amount of maternal and fetal DNA in an expectant mothers blood sample known as circulating cell-free DNA are now available These LDTs have not been cleared or approved by the US Food and Drug Administration FDA Although LDTs to date have not been subject to US FDA regulation certification of the laboratory is required under the Clinical Laboratory Improvement Amendments CLIA to ensure the quality and validity of the test
To sample collection study will obtain whole blood specimens from pregnant subjects to be used for development of prenatal assays to assist in the screening for fetal genetic abnormalities infectious and other diseases and blood group typing through detection of circulating cell-free DNA extracted from maternal plasma
Noninvasive laboratory-developed tests LDTs that detect an abnormal amount of maternal and fetal DNA in an expectant mothers blood sample known as circulating cell-free DNA are now available These LDTs have not been cleared or approved by the US Food and Drug Administration FDA Although LDTs to date have not been subject to US FDA regulation certification of the laboratory is required under the Clinical Laboratory Improvement Amendments CLIA to ensure the quality and validity of the test
To sample collection study will obtain whole blood specimens from pregnant subjects to be used for development of prenatal assays to assist in the screening for fetal genetic abnormalities infectious and other diseases and blood group typing through detection of circulating cell-free DNA extracted from maternal plasma
Detailed Description:
Eligible subjects will provide written informed consent after which basic demographic and clinical data will be collected
Study procedures involve the collection of 50 mL of whole blood at one or more monthly clinic visits 25 days apart from pregnant women 18 to 54 yrs of age carrying a single fetus of 8 to 22 weeks of gestational age inclusive
Study procedures involve the collection of 50 mL of whole blood at one or more monthly clinic visits 25 days apart from pregnant women 18 to 54 yrs of age carrying a single fetus of 8 to 22 weeks of gestational age inclusive
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