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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:
ClinicalTrials.gov Identifier:
NCT00891852
First Posted: May 1, 2009
Last Update Posted: May 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lenetix Medical Screening Laboratory
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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   
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   
New York Perinatal Associates Recruiting
New York, New York, United States, 10128
Contact: Daniel Saltzman, MD    201-370-5277    dsaltzman@mfmnyc.com   
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

Responsible Party: Leonard Kellner, Lenetix, Inc.
ClinicalTrials.gov Identifier: NCT00891852     History of Changes
Other Study ID Numbers: 110106-1
First Submitted: April 29, 2009
First Posted: May 1, 2009
Last Update Posted: May 4, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Syndrome
Congenital Abnormalities
Down Syndrome
Trisomy
Klinefelter Syndrome
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