Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies
This study is currently recruiting participants.
Verified May 2013 by Sequenom, Inc.
Sponsor:
Sequenom, Inc.
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01597063
First received: May 9, 2012
Last updated: May 14, 2013
Last verified: May 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 9, 2012 | ||||||||
| Last Updated Date | May 14, 2013 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Estimate the false positive rate of SEQureDx Trisomy 21 Test [ Time Frame: pregnancy outcome ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01597063 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 | Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies | ||||||||
| Official Title ICMJE | A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy | ||||||||
| Brief Summary | Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded. |
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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 | 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 | Probability Sample | ||||||||
| Study Population | Pregnant with low risk for fetal chromosome 21 aneuploidy |
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| Condition ICMJE |
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| Intervention ICMJE | Device: SEQureDx Trisomy Test
Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21. |
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| Study Group/Cohort (s) | low risk pregnancies
Intervention: Device: SEQureDx Trisomy Test |
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| Publications * |
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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 | 3000 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| 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 to 34 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01597063 | ||||||||
| Other Study ID Numbers ICMJE | SQNM-T21-303 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Sequenom, Inc. | ||||||||
| Study Sponsor ICMJE | Sequenom, Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Sequenom, Inc. | ||||||||
| Verification Date | May 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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