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NotablePhase changed: not applicable → not specifiedEligibility criteria expanded, about 8 words · Study description expanded, about 8 words · Publications: details revised at 4 of 4 entriesShow 3 more changesShow less
Eligibility criteria expanded, about 8 words
Study description expanded, about 8 words
Publications: details revised at 4 of 4 entries
MinorRe-verified, no change to tracked fieldsv235
MinorEnrollment target: 320 to 365v234
Minor3 versionsRe-verified since Jan 14, 2026, no change to tracked fieldsv231-v233
NotableLead sponsor: National Cancer Institute (NCI) to National Human Genome Research Institute (NHGRI)Primary and study completion dates: Dec 31, 2024 to Apr 30, 2029 · Study arms: 2 to 1v212Show 2 more changesShow less
Primary and study completion dates: Dec 31, 2024 to Apr 30, 2029
Study arms: 2 to 1
MinorRe-verified, no change to tracked fieldsv211
NotablePrimary and study completion dates: Dec 31, 2023 to Dec 31, 2024v210
Minor2 versionsRe-verified since Sep 30, 2023, no change to tracked fieldsv208-v209
MinorEnrollment target: 120 to 140v207
Minor9 versionsRe-verified since Oct 4, 2022, no change to tracked fieldsv198-v206
MinorStudy Identification, Study Status, Study Description, Conditions, Referencesv197
Minor10 versionsRe-verified since Jun 21, 2022, no change to tracked fieldsv187-v196
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.