What this study is
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 reportable. Researchers want to learn more about the relationship between these test results and cancer.
Objective:
To better understand prenatal DNA test results and how they can predict cancer, if present, in pregnant women.
Eligibility:
Women 18 and older who got prenatal DNA test results that were abnormal or not reportable and suggested the abnormality was in the woman and not her baby.
Design:
Potential participants will be screened by phone or in person. They will talk about their medical history and send copies of their medical records.
Eligible participants will have a physical exam and medical history. They will give blood and stool samples. They may have a Pap smear. They will talk to a specialist about the test results they got when they were pregnant.
Participants will have magnetic resonance imaging (MRI). They will lie on a table that slides in and out of a metal tube, taking pictures.
Participants will complete a paper or electronic survey. It will assess their emotional well-being.
Participants will get a list of any possible diagnoses and treatment options.
Participants may be followed for up to 5 years. They may give blood samples and copies of their medical records. This can be done without traveling to the NIH. In some cases, people might come back to the NIH in one year to see if anything has changed.
What's being tested
- NIPT
Intervention · DEVICE
noninvasive prenatal testing
Study details
- Official title
- Incidental Detection of Maternal Neoplasia Through Non-invasive Cell-Free DNA Analysis (IDENTIFY), a Natural History Study
- Sponsor
- National Human Genome Research Institute (NHGRI)
- Conditions
- Maternal Neoplasia
- Enrolling
- 365 people
- Starts
- 2019-12-23
- Est. completion
- 2029-04-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.; Normal-appearing fetus or fetuses on ultrasound examination and/or a normal fetal or neonatal karyotype. If a fetal anomaly is present but does not explain entirely the NIPT results, or there is a continuing concern for maternal cancer, the individual is still eligible for participation.
- 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.
You can't join if
- --Abnormal results that have been associated previously with an increased risk for hematologic malignancy, including but not limited to, Trisomy 8, 20delq, 5delq.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- NIH Clinical Center Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY dial 711ccopr@nih.gov
Recruiting
Study team
Sponsor
National Human Genome Research Institute (NHGRI)
Study ID 190132
Principal investigator
Benjamin D Solomon, M.D.
National Human Genome Research Institute (NHGRI)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.