Evaluation of a Noninvasive Fetal RHD Genotyping Test (IRIS)

This study has been completed.

Sponsor:

Collaborator:

Sequenom Center for Molecular Medicine

Information provided by (Responsible Party):

Sequenom, Inc.

ClinicalTrials.gov Identifier:

NCT01054716

First received: January 20, 2010

Last updated: September 1, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 20, 2010
Last Updated Date	September 1, 2011
Start Date ^ICMJE	May 2009
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 21, 2010)	Fetal RHD determination from maternal whole blood [ Time Frame: Between 10 and 28 weeks gestation ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01054716 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	Evaluation of a Noninvasive Fetal RHD Genotyping Test
Official Title ^ICMJE	Evaluation of a Noninvasive Fetal RHD Genotyping Test
Brief Summary	This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Whole blood collected, processed to plasma and buffy coat for DNA extraction.
Sampling Method	Non-Probability Sample
Study Population	Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.
Condition ^ICMJE	Rhesus D Genotype
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	500
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject is 18-64 years of age Subject is female Subject is pregnant Subject is RhD negative Subject is between 10 and 28 weeks gestation Subject provides informed consent Subject agrees to provide neonatal RHD and sex outcome Exclusion Criteria: None
Gender	Female
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01054716
Other Study ID Numbers ^ICMJE	SQNM-RHD-105
Has Data Monitoring Committee	No
Responsible Party	Sequenom, Inc.
Study Sponsor ^ICMJE	Sequenom, Inc.
Collaborators ^ICMJE	Sequenom Center for Molecular Medicine
Investigators ^ICMJE	Not Provided
Information Provided By	Sequenom, Inc.
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top