Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
| Tracking Information | |||||
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| First Received Date ICMJE | September 2, 2011 | ||||
| Last Updated Date | April 10, 2013 | ||||
| Start Date ICMJE | May 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01429389 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy | ||||
| Official Title ICMJE | Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Aneuploidy for Use in Development of the SEQureDx Trisomy 21 Test in the Detection of the Relative Quantity of Chromosome 21 Circulating Cell-Free DNA Extracted From Maternal Plasma | ||||
| Brief Summary | The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21. |
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| Detailed Description | To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood specimens will be collected and processed to plasma. DNA will be extracted from the plasma. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Pregnant women between 10 and 22 weeks of gestation who are scheduled to undergo a CVS or amniocentesis procedure and will receive the fetal FISH, karyotype and/or QF-PCR results from the procedure. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 2000 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01429389 | ||||
| Other Study ID Numbers ICMJE | SQNM-T21-107 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sequenom, Inc. | ||||
| Study Sponsor ICMJE | Sequenom, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sequenom, Inc. | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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