Non-Invasive Determination of Fetal Chromosome Abnormalities
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| ClinicalTrials.gov Identifier: NCT00891852 |
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Recruitment Status : Unknown
Verified April 2009 by Lenetix Medical Screening Laboratory.
Recruitment status was: Recruiting
First Posted : May 1, 2009
Last Update Posted : May 1, 2009
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Sponsor:
Lenetix Medical Screening Laboratory
Information provided by:
Lenetix Medical Screening Laboratory
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Brief Summary:
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 or disease |
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| Down Syndrome (Trisomy 21) Edward's Syndrome (Trisomy 18) Patau Syndrome (Trisomy 13) Klinefelter Syndrome (47, XXY) and Other Chromosome Abnormalities. |
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Non-Invasive Determination of Fetal Chromosome Abnormalities |
| Study Start Date : | January 2009 |
| Estimated Primary Completion Date : | December 2009 |
| Estimated Study Completion Date : | December 2009 |
Resource links provided by the National Library of Medicine
Biospecimen Retention: Samples With DNA
Plasma
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
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. |
| Responsible Party: | Leonard Kellner, Lenetix, Inc. |
| ClinicalTrials.gov Identifier: | NCT00891852 |
| Other Study ID Numbers: |
110106-1 |
| First Posted: | May 1, 2009 Key Record Dates |
| Last Update Posted: | May 1, 2009 |
| Last Verified: | April 2009 |
Additional relevant MeSH terms:
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Chromosome Disorders Sex Chromosome Disorders of Sex Development Sex Chromosome Disorders Down Syndrome Trisomy 13 Syndrome Klinefelter Syndrome Trisomy 18 Syndrome Congenital Abnormalities Syndrome Trisomy Chromosome Aberrations 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 Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |