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Non-Invasive Determination of Fetal Chromosome Abnormalities

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Lenetix Medical Screening Laboratory.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lenetix Medical Screening Laboratory
ClinicalTrials.gov Identifier:
NCT00891852
First received: April 29, 2009
Last updated: April 30, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition
Down Syndrome (Trisomy 21)
Edward's Syndrome (Trisomy 18)
Patau Syndrome (Trisomy 13)
Klinefelter Syndrome (47, XXY)
and Other Chromosome
Abnormalities.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Non-Invasive Determination of Fetal Chromosome Abnormalities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lenetix Medical Screening Laboratory:

Biospecimen Retention:   Samples With DNA

Plasma


Estimated Enrollment: 1000
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891852

Locations
United States, Maryland
Maryland Perinatal Associates Recruiting
Rockville, Maryland, United States, 20850
Contact: Elizabeth Kramer, GC     301-251-8611     ekramer@lenetix.com    
United States, New Jersey
Atlantic Maternal Fetal Medicine Recruiting
Moristown, New Jersey, United States, 07960
Contact: Diane London, Perinatal Nurse     973-971-7080     diane.london@atlantichealth.com    
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Martin Chavez, MD     516-663-3020     mchavez@winthrop.org    
Elite Women's Health Recruiting
New Hyde Park, New York, United States, 11042
Contact: Jonathan D Herman, MD     516-358-1200     jdherman@gmail.com    
New York Perinatal Associates Recruiting
New York, New York, United States, 10128
Contact: Daniel Saltzman, MD     201-370-5277     dsaltzman@mfmnyc.com    
Columbia University, NewYork-Presbyterian Hospital Recruiting
New York, New York, United States, 10022
Contact: Erica Speigel, GC     212-305-1327     ess2113@columbia.edu    
Contact: Anne Van Der Veer     212-305-1327     av2284@columbia.edu    
United States, Vermont
UVM Recruiting
Burlington, Vermont, United States, 05405
Contact: Stephen A Brown, MD     802-656-4775     stephen.brown@uvm.edu    
Sponsors and Collaborators
Lenetix Medical Screening Laboratory
Investigators
Principal Investigator: Stephen A Brown, MD Lenetix, Inc.
  More Information

No publications provided

Responsible Party: Leonard Kellner, Lenetix, Inc.
ClinicalTrials.gov Identifier: NCT00891852     History of Changes
Other Study ID Numbers: 110106-1
Study First Received: April 29, 2009
Last Updated: April 30, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Abnormalities, Multiple
Urogenital Abnormalities
Chromosome Aberrations
Chromosome Disorders
Down Syndrome
Klinefelter Syndrome
Trisomy
Pathologic Processes
Genetic Diseases, Inborn
Mental Retardation
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Sex Chromosome Disorders
Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Aneuploidy
Chromosome Duplication

ClinicalTrials.gov processed this record on May 23, 2013