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Non-Invasive Determination of Fetal Chromosome Abnormalities

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Maryland Perinatal Associates
Rockville, Maryland, United States, 20850
United States, New Jersey
Atlantic Maternal Fetal Medicine
Moristown, New Jersey, United States, 07960
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Elite Women's Health
New Hyde Park, New York, United States, 11042
Columbia University, NewYork-Presbyterian Hospital
New York, New York, United States, 10022
New York Perinatal Associates
New York, New York, United States, 10128
United States, Vermont
UVM
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
Lenetix Medical Screening Laboratory
Investigators
Principal Investigator: Stephen A Brown, MD Lenetix, Inc.
  More Information

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:
Klinefelter Syndrome
Syndrome
Congenital Abnormalities
Down Syndrome
Trisomy
Chromosome Aberrations
Chromosome Disorders
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Genetic Diseases, Inborn
Aneuploidy
Chromosome Duplication
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Gonadal Disorders
Endocrine System Diseases
Hypogonadism

ClinicalTrials.gov processed this record on December 02, 2016