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Protocol Details

Incidental Detection of Maternal Neoplasia Through Non-invasive Cell-Free DNA Analysis (IDENTIFY), a Natural History Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-C-0132

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Male;
Children

Keywords

Prenatal Clinical Care;
Prenatal Screen;
Pregnant Women;
Predictive Values;
Natural History;
Cell-Free DNA (cfDNA) test

Recruitment Keyword(s)

None

Condition(s)

Maternal Neoplasia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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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.

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Eligibility

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 "test failure" 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.

-Women undergoing active treatment or surveillance for known malignancy may enroll, so that their DNA profiles will serve as positive controls.

-Study enrollment may occur during pregnancy or up to two years postpartum.

-Ability to travel to NIH, unless undergoing active treatment for known malignancy.

-Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

- None


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Citations:

Turriff AE, Annunziata CM, Bianchi DW. Prenatal DNA Sequencing for Fetal Aneuploidy Also Detects Maternal Cancer: Importance of Timely Workup and Management in Pregnant Women. J Clin Oncol. 2022 Jun 15:JCO2200733. doi: 10.1200/JCO.22.00733. Epub ahead of print. PMID: 35704839.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Padma S. Rajagopal, M.D.
National Cancer Institute (NCI)
NIHBC 41 BG RM A100A
41 CENTER DR
BETHESDA MD 20892
(240) 858-3169
sheila.rajagopal@nih.gov

Amy E. Turriff
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 10N226
10 Center Drive
Bethesda, Maryland 20892
(301) 402-5421
turriffa@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04049604

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