Development of a Prenatal Test for Fetal Aneuploidy Detection
This study is currently recruiting participants.
Verified January 2013 by Ariosa Diagnostics, Inc
Sponsor:
Ariosa Diagnostics, Inc
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01451671
First received: October 10, 2011
Last updated: January 8, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 10, 2011 | ||||||||
| Last Updated Date | January 8, 2013 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | November 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Identification of aneuploidy [ Time Frame: At enrollment ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01451671 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 | Development of a Prenatal Test for Fetal Aneuploidy Detection | ||||||||
| Official Title ICMJE | Prenatal Test for Fetal Aneuploidy Detection | ||||||||
| Brief Summary | This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Tandem. |
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| Detailed Description | Not Provided | ||||||||
| 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 | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing. |
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| Condition ICMJE | Fetal Complications | ||||||||
| 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 | 500 | ||||||||
| Estimated Completion Date | November 2015 | ||||||||
| Estimated Primary Completion Date | November 2015 (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 |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01451671 | ||||||||
| Other Study ID Numbers ICMJE | TD002 | ||||||||
| 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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