IDENTIFY Study: Natural History of Maternal Neoplasia

Conditions

• Maternal Neoplasia

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• NIPT — DEVICE
  noninvasive prenatal testing

Study Details

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.

Key Dates

Start date

Dec 23, 2019

Status verified

Feb 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

365 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Arms

• Other: 1
  Women with prenatal testing results that suggest an incidental detection of maternal neoplasia

Primary Outcome Measure

To study the natural history of women with prenatal testing results that suggest an incidental detection of maternal neoplasia [ Time Frame: 5 years ]

Central Contacts

• Amy E Turriff
  (301) 402-5421
  [email protected]
• Benjamin D Solomon, M.D.
  (301) 402-8824
  [email protected]

Locations (1)

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