Trial record 1 of 1 for:
Open Studies | chorionic villi sampling
Noninvasive Screening for Fetal Aneuploidy: Assay Development & Optimization in Affected Pregnancies (CHARMM-AP)
This study is currently recruiting participants.
Verified November 2012 by Sequenom, Inc.
Sponsor:
Sequenom, Inc.
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01052688
First received: January 15, 2010
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
To collect samples for the purpose of developing and optimizing a prenatal aneuploidy test using circulating cell free nucleic acid from blood samples from pregnant women who are known to have a fetus diagnosed with an aneuploidy in the current pregnancy. The results of the ccff aneuploidy screening test will be compared to the results obtained through standard chromosome analysis procedures such as Karyotype, FISH and/or QF-PCR
| Condition | Intervention |
|---|---|
|
Down Syndrome Aneuploidy |
Other: Maternal blood draw of 30 to 50ml |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Noninvasive Screening for Fetal Aneuploidy: Assay Development & Optimization in Affected Pregnancies |
Resource links provided by NLM:
Further study details as provided by Sequenom, Inc.:
Biospecimen Retention: Samples With DNA
Plasma, white blood cells
| Estimated Enrollment: | 90 |
| Study Start Date: | November 2009 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Pregnant Women
Pregnant women who have been definitively diagnosed as carrying a fetus with aneuploidy.
|
Other: Maternal blood draw of 30 to 50ml
Maternal blood draw of 30 to 50mls during pregnancy. Blood may be drawn up to 5 times during the pregnancy between weeks 8 and 36 gestation.
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Pregnant women who have been definitively diagnosed by amniocentesis, CVS or QF/PCR as carrying a fetus with aneuploidy
Criteria
Inclusion Criteria:
- Subject is female
- Subject is 18 years or older
- Subject is no less than 8 and no more than 36 weeks gestation
- Subject provides a signed and dated informed consent
- Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol
- Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21)
Exclusion Criteria:
- Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052688
Locations
| United States, Arizona | |
| Perinatal Care Associates | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Summer Pierson 602-263-0222 spierson@perinatalcare.com | |
| Principal Investigator: John Garbaciak, MD | |
| St. Joseph's Hospital and medical Center | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Kelli Williamson 602-406-6689 Kelli.Williamson@chw.edu | |
| Principal Investigator: James Balducci, MD | |
| United States, California | |
| San Diego Perinatal Center | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Perla Gomez 858-939-6880 pgomez@rchsd.org | |
| Principal Investigator: Larry Cousins, MD | |
| Sub-Investigator: Holly Casele, MD | |
| Women's Healthcare at Frost Street | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Study Coordinator 858-505-8672 | |
| Principal Investigator: Rovena Reagan, MD | |
| IGO | Recruiting |
| San Diego, California, United States, 92121 | |
| Contact: Emily Cardey 858-455-1248 ext 137 ecardey@igomed.com | |
| Principal Investigator: Wendy Buchi, Md | |
| Sharp Grossmount | Recruiting |
| San Diego, California, United States, 91944 | |
| Contact: Mary Lepage 619-894-3028 | |
| Principal Investigator: Christopher Lafferty, MD | |
| United States, District of Columbia | |
| Reiter, Hill, Johnson and Nevin | Recruiting |
| Washington, District of Columbia, United States, 20036 | |
| Contact: Susannah Dyer 202-331-1740 | |
| Principal Investigator: Kristiann Nevin, MD | |
| United States, Hawaii | |
| Fetal Diagnostic Institute of the Pacific | Recruiting |
| Honolulu, Hawaii, United States, 96814 | |
| Contact: Melissa Bitanga 858-945-2265 melissa.b@hawaiiantel.net | |
| Principal Investigator: Greigh I Hirata, MD | |
| United States, Michigan | |
| Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Lori Oosterman 616-486-2085 lori.oosterman@spectrum-health.org | |
| Principal Investigator: Assad Sheikh, MD | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02902-2499 | |
| Contact: Jacquelyn Halliday 401-453-7515 JHalliday@WIHRI.org | |
| Principal Investigator: Barbara O'Brien, MD | |
Sponsors and Collaborators
Sequenom, Inc.
Investigators
| Study Director: | Allan T. Bombard, M.D. | Sequenom, Inc. |
More Information
No publications provided
| Responsible Party: | Sequenom, Inc. |
| ClinicalTrials.gov Identifier: | NCT01052688 History of Changes |
| Other Study ID Numbers: | SQNM T21-305 |
| Study First Received: | January 15, 2010 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sequenom, Inc.:
|
Down syndrome, aneuploidy, amniocentesis, chorionic villus sampling, Trisomy |
Additional relevant MeSH terms:
|
Aneuploidy Down Syndrome Chromosome Aberrations Pathologic Processes Mental Retardation Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 22, 2013