Status:
RECRUITING
IDENTIFY Study: Natural History of Maternal Neoplasia
Lead Sponsor:
National Human Genome Research Institute (NHGRI)
Conditions:
Maternal Neoplasia
Eligibility:
FEMALE
18-100 years
Phase:
NA
Brief Summary
Background: Pregnant women can get a DNA analysis of their blood. The test tells a woman and her doctor about the DNA of her unborn baby. But some women get test results that are abnormal or not repo...
Detailed Description
Background: * Starting in 2011, analysis of circulating cell-free DNA (cfDNA) in the plasma of pregnant women began to be offered clinically as a prenatal screen for trisomies 13, 18, and 21. Owing t...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Women, age \>= 18 years.
- Pregnancy for which the following applies:
- \-- Underwent blood noninvasive prenatal testing (NIPT) during pregnancy to screen for fetal chromosomal aneuploidies and had unusual results that either led to an interpretation of "non-reportable" or multiple aneuploidies inconsistent with a viable fetus.
- Follow up testing shows a normal-appearing fetus or fetuses on ultrasound examination and/or a normal fetal or neonatal karyotype.
- Study enrollment may occur during pregnancy or up to two years postpartum.
- Ability to travel to NIH.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- EXCLUSION CRITERIA:
- The following NIPT results will be excluded:
- -Abnormal results that have been associated previously with an increased risk for hematologic malignancy, including but not limited to, Trisomy 8, 20delq, 5delq.
Exclusion
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04049604
Start Date
December 23 2019
End Date
April 30 2029
Last Update
December 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892