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
Recruitment status was Recruiting
Sponsor:
Lenetix Medical Screening Laboratory
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
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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
persistent Müllerian duct syndrome
tetrasomy 18p
trisomy 13
trisomy 18
Genetic and Rare Diseases Information Center resources:
Chromosomal Triplication
Klinefelter Syndrome
Mohr-Tranebjaerg Syndrome
U.S. FDA Resources
Further study details as provided by Lenetix Medical Screening Laboratory:
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
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
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
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:
|
Chromosome Aberrations Chromosome Disorders Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Congenital Abnormalities Klinefelter Syndrome Syndrome Trisomy Aneuploidy |
Chromosome Duplication Disease Disorders of Sex Development Endocrine System Diseases Genetic Diseases, Inborn Gonadal Disorders Hypogonadism Pathologic Processes Urogenital Abnormalities |
ClinicalTrials.gov processed this record on February 27, 2015