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Non-Invasive Determination of Fetal Chromosome Abnormalities

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ClinicalTrials.gov Identifier: NCT00891852
Recruitment Status : Unknown
Verified April 2009 by Lenetix Medical Screening Laboratory.
Recruitment status was:  Recruiting
First Posted : May 1, 2009
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:
Lenetix Medical Screening Laboratory

Tracking Information
First Submitted Date April 29, 2009
First Posted Date May 1, 2009
Last Update Posted Date May 1, 2009
Study Start Date January 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Invasive Determination of Fetal Chromosome Abnormalities
Official Title Non-Invasive Determination of Fetal Chromosome Abnormalities
Brief Summary The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population The investigators anticipate enrolling 1000 subjects who are presenting for prenatal diagnosis by CVS or genetic amniocentesis for increased risk for fetal aneuploidy.
Condition
  • Down Syndrome (Trisomy 21)
  • Edward's Syndrome (Trisomy 18)
  • Patau Syndrome (Trisomy 13)
  • Klinefelter Syndrome (47, XXY)
  • and Other Chromosome
  • Abnormalities.
Intervention Not Provided
Study Groups/Cohorts 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 Unknown status
Estimated Enrollment
 (submitted: April¬†30,¬†2009)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.

Exclusion Criteria:

  • The only exclusion criteria are those mentioned.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00891852
Other Study ID Numbers 110106-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Leonard Kellner, Lenetix, Inc.
Study Sponsor Lenetix Medical Screening Laboratory
Collaborators Not Provided
Investigators
Principal Investigator: Stephen A Brown, MD Lenetix, Inc.
PRS Account Lenetix Medical Screening Laboratory
Verification Date April 2009