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Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
This study is currently recruiting participants.
Verified October 2016 by Sequenom, Inc.
Sponsor:
Sequenom, Inc.
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01429389
First received: September 2, 2011
Last updated: October 27, 2016
Last verified: October 2016
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Purpose
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
| Condition |
|---|
| Down Syndrome Fetal Aneuploidy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted From Maternal Plasma |
Resource links provided by NLM:
Genetics Home Reference related topics:
Down syndrome
MedlinePlus related topics:
Down Syndrome
U.S. FDA Resources
Further study details as provided by Sequenom, Inc.:
Biospecimen Retention: Samples With DNA
Detailed Description:
Whole blood specimens will be collected and processed to plasma. DNA will be extracted from the plasma.
| Estimated Enrollment: | 2000 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | March 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pregnant women between 10 and 22 weeks of gestation who are scheduled to undergo a CVS or amniocentesis procedure and will receive the fetal FISH, karyotype and/or QF-PCR results from the procedure.
Criteria
Inclusion Criteria:
- pregnant between 10 and 22 weeks gestation
- 18 years of age or older
- provides signed and dated informed consent
- subject is at increased risk for fetal aneuploidy
- subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
- subject agrees to provide the genetic results of the invasive procedure
Exclusion Criteria:
- Fetal demise at time of specimen sampling
- Previous sample donation under this protocol
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: NCT01429389
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429389
Locations
| United States, Alabama | |
| University of Alabama Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Rachel Copper 205-934-5509 rachel.copper@obgyn.uab.edu | |
| Principal Investigator: Joseph Biggio, MD | |
| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Deebra Smith, MD 310-423-5860 | |
| Principal Investigator: John Williams, MD | |
| Sharp-Rees Stealy Medical Group | Recruiting |
| San Diego, California, United States, 92101 | |
| Contact: Mary LaPage 619-446-1624 | |
| Principal Investigator: Denis Tarakjian, MD | |
| UCSD | Recruiting |
| San Diego, California, United States, 92121 | |
| Contact: Jason Chibuck jchibuck@ucsd.edu | |
| Principal Investigator: Andrew Hull, MD | |
| Women's Health Care Research | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Nora Martinez 858-505-8672 research@womenwellness.com | |
| Principal Investigator: Rovena Reagan, MD | |
| Specialty Obstetrics of San Diego | Recruiting |
| San Diego, California, United States, 92130 | |
| Contact: Deborah Malone 858-794-7700 d.malone@specialtyobstetrics.com | |
| Principal Investigator: David Dowling, MD | |
| United States, Illinois | |
| Reproductive Genetics Institute | Recruiting |
| Chicago, Illinois, United States, 60602 | |
| Contact: Denise Ginsberg 773-472-4900 | |
| Principal Investigator: Norman Ginsberg, MD | |
| United States, Iowa | |
| University of Iowa Health Care | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Diedre Fleener 319-356-2913 deidre-fleener@uiowa.edu | |
| Principal Investigator: Kristi Borowski, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Ellen Martindell 313-916-3190 emartin1@hfhs.org | |
| Principal Investigator: Jacquelyn Roberson, MD | |
| Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Yvonne Edgerly 616-391-5066 | |
| Principal Investigator: Asad Sheikh, MD | |
| United States, New Jersey | |
| The Cooper Health System | Recruiting |
| Camden, New Jersey, United States | |
| Contact: Clare Hanson hansen-clare@cooperhealth.edu | |
| Principal Investigator: Meena Khandelwal, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29466 | |
| Contact: Betty Oswald 843-792-0347 oswaldbw@musc.edu | |
| Principal Investigator: Christopher Robinson, MD | |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Contact: Cora Fanning 902 470-7158 cora.fanning@iwk.nshealth.ca | |
| Principal Investigator: Jo-Ann Brock, MD | |
| Canada, Ontario | |
| North York General Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Clare Gibbons 416 756-6788 clare.gibbons@nygh.on.ca | |
| Principal Investigator: Wendy Meschino, MD | |
Sponsors and Collaborators
Sequenom, Inc.
Investigators
| Study Director: | Daniel Grosu, MD | Sequenom, Inc. |
More Information
| Responsible Party: | Sequenom, Inc. |
| ClinicalTrials.gov Identifier: | NCT01429389 History of Changes |
| Other Study ID Numbers: |
SQNM-T21-107 |
| Study First Received: | September 2, 2011 |
| Last Updated: | October 27, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Samples are used for research and development of a noninvasive prenatal test. However, samples used for publications will have data shared as defined by journal. |
Keywords provided by Sequenom, Inc.:
|
Down syndrome fetal aneuploidy trisomy noninvasive screening test |
Additional relevant MeSH terms:
|
Down Syndrome Aneuploidy Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Chromosome Aberrations Pathologic Processes |
ClinicalTrials.gov processed this record on July 17, 2017