Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
NCT02787486 · View on ClinicalTrials.gov ↗
Study Summary
In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal abnormalities including biochemical screening tests and invasive procedures such as CVS or amniocentesis is available, regardless of age. Further, it is entirely up to the patient to decide whether or not she wishes to be screened for fetal chromosomal abnormalities without judgment from the physician. Noninvasive laboratory-developed tests (LDTs) that detect an abnormal amount of maternal and fetal DNA in an expectant mother's blood sample (known as circulating cell-free DNA) are now available. These LDTs have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although LDTs to date have not been subject to U.S. FDA regulation, certification of the laboratory is required under the Clinical Laboratory Improvement Amendments (CLIA) to ensure the quality and validity of the test. To sample collection study will obtain whole blood specimens from pregnant subjects to be used for development of prenatal assays to assist in the screening for fetal genetic abnormalities, infectious and other diseases, and blood group typing through detection of circulating cell-free DNA extracted from maternal plasma.
Conditions Studied
Interventions
- OTHER Blood sampling for Laboratory Developed Test (LDT) analysis
Study Locations (8)
Ohio
- Cincinnati Obgyn — Cincinnati
- James D. Kasten, M.D., Inc. — Norwalk
Arizona
- Valley Perinatal — Scottsdale
Louisiana
- Heinen Obstectrics & Gynecology — Eunice
New York
- Newlife Wellness OBGYN — Brooklyn
North Carolina
- Lakeshore Women's Specialists — Mooresville
Tennessee
- Regional Obstetrical Consultants — Chattanooga
Texas
- Texas Maternal-Fetal Medicine — Webster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 760 participants |
| Start Date | 2015-10 |
| Est. Completion | 2018-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02787486
The ClinicalTrials.gov registry entry for NCT02787486 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 760 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Progenity, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Blood sampling for Laboratory Developed Test (LDT) analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02787486 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Ohio, Arizona, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02787486 about?
NCT02787486 is a clinical study titled "Expanded Noninvasive Genomic Medical Assessment: The Enigma Study". In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal abnormalities including biochemical screening tests and invasive proce...
What is the current status of trial NCT02787486?
This trial is currently completed. The enrollment target is 760 participants. The study started on 2015-10. Estimated completion is 2018-09.
What conditions does trial NCT02787486 study?
This clinical trial studies the following conditions: Down Syndrome, Turner Syndrome, Aneuploidy, DiGeorge Syndrome, Klinefelter Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02787486?
The interventions under investigation include: Blood sampling for Laboratory Developed Test (LDT) analysis (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02787486?
This trial is sponsored by Progenity, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02787486 being conducted?
This trial has 8 study locations across Arizona, Louisiana, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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