Prenatal Test for Fetal Aneuploidy Detection
This study has been completed.
Sponsor:
Ariosa Diagnostics, Inc
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01256606
First received: November 22, 2010
Last updated: January 8, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | November 22, 2010 | ||||
| Last Updated Date | January 8, 2013 | ||||
| Start Date ICMJE | August 2010 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection [ Time Frame: 24 months ] [ Designated as safety issue: No ] Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01256606 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 | Prenatal Test for Fetal Aneuploidy Detection | ||||
| Official Title ICMJE | Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy | ||||
| Brief Summary | The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| 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 | Completed | ||||
| Enrollment ICMJE | 4000 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01256606 | ||||
| Other Study ID Numbers ICMJE | TT001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ariosa Diagnostics, Inc | ||||
| Study Sponsor ICMJE | Ariosa Diagnostics, Inc | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ariosa Diagnostics, Inc | ||||
| Verification Date | January 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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