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NCT01852708 · ClinicalTrials.gov registry record
Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood
A clinical trial of Trisomy 21 and Trisomy 18, sponsored by Natera.
- Completed
- Registry status
- 1,059
- Enrollment target
- 9
- Study locations
NCT01852708: Completed study of Trisomy 21 and Trisomy 18, sponsored by Natera.
NCT01852708 is a study of Trisomy 21 and Trisomy 18 that has completed, run by Natera. The registered enrollment target is 1,059 participants, above the 655-participant average among 5 other Trisomy 21 trials with a reported enrollment target (62% higher). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01852708, a study of Trisomy 21 and Trisomy 18, has completed, sponsored by Natera.
- COMPLETED
- Registry status
- 1,059 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.
Primary Outcome
Sensitivity and Specificity of the test to diagnose microdeletions (eg. 22q and 5p-) and aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y.
Conditions Studied
Study Locations (9)
California
- Natera, Inc. - San Carlos
- MFM Group of Southern CA - San Gabriel
Other
- Hospital Materno Infantil Vall d'Hebron - Barcelona
- GenePhile Biosciences - Taipei
District of Columbia
- Washington Women's Wellness Center - Washington D.C.
New Jersey
- Saint Peter's University Hospital - New Brunswick
New York
- Columbia University - New York
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Texas
- Dr. Meltzer Clinic - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,059 participants |
| Start Date | 2012-11 |
| Est. Completion | 2020-10 |
What the finished NCT01852708 record still lists
NCT01852708 is an observational study that tracks outcomes without assigning an intervention. Its 1,059 participants enrollment target places it among the larger protocols in the corpus, above the 655-participant average among 5 other Trisomy 21 trials with a reported enrollment target (62% higher).
The record links to 5 conditions, with Trisomy 21 appearing as the primary indexed condition, and to 0 interventions.
NCT01852708 lists 9 locations in 7 states (California, Other, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT01852708 about?
NCT01852708 is a clinical study titled "Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood". The purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal DNA isolated from m...
What is the current status of trial NCT01852708?
This trial is currently completed. The enrollment target is 1,059 participants. The study started on 2012-11. Estimated completion is 2020-10.
What conditions does trial NCT01852708 study?
This clinical trial studies the following conditions: Trisomy 21, Trisomy 18, Trisomy 13, Sex Chromosome Abnormalities, Microdeletion Syndromes.
Who is sponsoring clinical trial NCT01852708?
This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01852708 being conducted?
This trial has 9 study locations across California, District of Columbia, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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