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NCT04049604 · ClinicalTrials.gov registry record · NA
IDENTIFY Study: Natural History of Maternal Neoplasia
A NA study of Maternal Neoplasia, sponsored by National Human Genome Research Institute (NHGRI).
- Recruiting
- Registry status
- NA
- Development phase
- 365
- Enrollment target
- 1
- Study location
NCT04049604: Recruiting NA study of Maternal Neoplasia, sponsored by National Human Genome Research Institute (NHGRI).
NCT04049604 is a NA study of Maternal Neoplasia that is actively recruiting participants, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 365 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04049604, a NA study of Maternal Neoplasia, is actively recruiting participants, sponsored by National Human Genome Research Institute (NHGRI).
- RECRUITING
- Registry status
- NA
- Development phase
- 365 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Natural history of women with prenatal testing results that suggest an incidental detection of maternal neoplasia
Conditions Studied
Interventions
- DEVICE NIPT
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2019-12-23 |
| Est. Completion | 2029-04-30 |
| Phase | NA |
What NCT04049604 shows while recruiting
NCT04049604 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Maternal Neoplasia appearing as the primary indexed condition, and to 1 intervention - of which NIPT is the first listed.
NCT04049604 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04049604 about?
NCT04049604 is a clinical study titled "IDENTIFY Study: Natural History of Maternal Neoplasia". 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....
What is the current status of trial NCT04049604?
This trial is currently recruiting. It is a NA study. The enrollment target is 365 participants. The study started on 2019-12-23. Estimated completion is 2029-04-30.
What conditions does trial NCT04049604 study?
This clinical trial studies the following conditions: Maternal Neoplasia.
What interventions are being tested in trial NCT04049604?
The interventions under investigation include: NIPT (DEVICE).
Who is sponsoring clinical trial NCT04049604?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04049604 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04049604's enrollment target sits among peer trials
365 284th of 2000 higher than 1,717 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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