IDENTIFY Study: Natural History of Maternal Neoplasia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-100
SponsorNational Human Genome Research Institute (NHGRI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women, age >= 18 years.

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.

Disqualifiers

None

Trial population

Primary clinical

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NIPT

    Device

    noninvasive prenatal testing

Treatment groups

365 Participants
are divided into 1 treatment group
Group A: 11 intervention

Trial outcomes

Primary outcomes

1

To study the natural history of women with prenatal testing results that suggest an incidental detection of maternal neoplasia

Natural history of women with prenatal testing results that suggest an incidental detection of maternal neoplasia

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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