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

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:

Genetics Home Reference related topics: Down syndrome Klinefelter syndrome trisomy 13 trisomy 18

Genetic and Rare Diseases Information Center resources: Trisomy 18 Trisomy 13 Chromosomal Triplication

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 (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

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	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
Study First Received:	April 29, 2009
Last Updated:	April 30, 2009

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 21, 2017

To Top