Trial record 2 of 6 for:
"Trisomy 13"
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
This study has been completed.
Sponsor:
Sequenom, Inc.
Information provided by:
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT00770458
First received: October 8, 2008
Last updated: January 4, 2010
Last verified: January 2010
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Purpose
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.
| Condition |
|---|
|
Down Syndrome (Trisomy 21) Edwards Syndrome (Trisomy 18) Patau Syndrome (Trisomy 13) Turner Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker |
Resource links provided by NLM:
Genetics Home Reference related topics:
Down syndrome
persistent Müllerian duct syndrome
tetrasomy 18p
trisomy 13
trisomy 18
Turner syndrome
U.S. FDA Resources
Further study details as provided by Sequenom, Inc.:
Primary Outcome Measures:
- Compare investigational assay results for Down Syndrome to standard of care results. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Pregnant women
Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Fetal care and genetic counseling patients.
Criteria
Inclusion Criteria:
- Subject is female
- Subject is pregnant
- Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
- Subject is willing to provide blood specimen
Exclusion Criteria:
- Subject is not pregnant
- Subject is not willing to provide blood specimen
- Subject is not haveing aneuploid screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770458
Locations
| United States, California | |
| UCSD Fetal Care & Genetics Center | |
| La Jolla, California, United States, 92037 | |
| San Diego Perinatal Center | |
| San Diego, California, United States, 92123 | |
| Obstetrix Medical Group of San Jose | |
| San Jose, California, United States, 95008 | |
| United States, Colorado | |
| Obstetrix Medical Group of Colorado | |
| Denver, Colorado, United States, 80218 | |
| United States, Rhode Island | |
| Women & Infants | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Utah | |
| A.R.U.P. | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Washington | |
| Obstetrix Medical Group of Washington | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
Sequenom, Inc.
Investigators
| Study Director: | Allan Bombard, MD | Sequenom, Inc. |
More Information
No publications provided
| Responsible Party: | Elizabeth Dragon / Sr. VP Research & Development, Sequenom, Inc. |
| ClinicalTrials.gov Identifier: | NCT00770458 History of Changes |
| Other Study ID Numbers: | SQNM-Trisomy21-0100 |
| Study First Received: | October 8, 2008 |
| Last Updated: | January 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sequenom, Inc.:
|
Down Syndrome |
Additional relevant MeSH terms:
|
Aneuploidy Down Syndrome Trisomy Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Chromosome Disorders Chromosome Aberrations Pathologic Processes Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities |
Genetic Diseases, Inborn Chromosome Duplication Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Sex Chromosome Disorders Gonadal Disorders Endocrine System Diseases Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 22, 2013