RECRUITING

IDENTIFY Study: Natural History of Maternal Neoplasia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-23
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04049604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women, age \>= 18 years.
  2. * Pregnancy for which the following applies:
  3. * Follow up testing shows a normal-appearing fetus or fetuses on ultrasound examination and/or a normal fetal or neonatal karyotype.
  4. * Study enrollment may occur during pregnancy or up to two years postpartum.
  5. * Ability to travel to NIH.
  6. * Ability of subject to understand and the willingness to sign a written informed consent document.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amy E Turriff
CONTACT
(301) 402-5421
turriffa@mail.nih.gov
Diana W Bianchi, M.D.
CONTACT
(301) 496-9454
bianchidw@mail.nih.gov

Principal Investigator

Diana W Bianchi, M.D.
PRINCIPAL_INVESTIGATOR
National Human Genome Research Institute (NHGRI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Human Genome Research Institute (NHGRI)

  • Diana W Bianchi, M.D., PRINCIPAL_INVESTIGATOR, National Human Genome Research Institute (NHGRI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-23
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2019-12-23
Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

  • Non invasive Prenatal Screening (NIPT or NIPS)
  • Prenatal Clinical Care
  • Pregnant Women
  • Maternal Malignancy
  • Cell-Free DNA (cfDNA) test

Additional Relevant MeSH Terms

  • Maternal Neoplasia