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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01597063
Other study ID # SQNM-T21-303
Secondary ID
Status Completed
Phase N/A
First received May 9, 2012
Last updated April 18, 2016
Start date July 2012
Est. completion date December 2015

Study information

Verified date April 2016
Source Sequenom, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.


Recruitment information / eligibility

Status Completed
Enrollment 3333
Est. completion date December 2015
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 34 Years
Eligibility Inclusion Criteria:

- Pregnancy is 10-22 weeks gestation

- Between 18-34 years of age inclusive at estimated date of delivery

- No prenatal screening indicators for high risk including serum biochemical and ultrasound screening

- No personal or family history of Down syndrome

- Willing to provide written informed consent

- Willing to provide a whole blood sample

- Willing to provide access to medical records supporting fetal outcome

Exclusion Criteria:

- Fetal demise at the time of the blood draw

- Previous specimen donation under this protocol

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
SEQureDx Trisomy Test
Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.

Locations

Country Name City State
United States New Horizon Women's Care Chandler Arizona
United States Medical University of South Carolina Charleston South Carolina
United States Providence Health Partners - Center for Clinical Research Dayton Ohio
United States Descanso OBGYN Glendale California
United States Woodglen Medical Group Glendora California
United States Spectrum Health - Maternal Fetal Medicine Grand Rapids Michigan
United States Hawaii Pacific Health Honolulu Hawaii
United States University of Iowa Health Care Iowa City Iowa
United States University of Kansas Medical Center Kansas City Kansas
United States White Memorial GYN/OB Medical Group Los Angeles California
United States University of South Alabama Mobile Alabama
United States Virtua Health Moorestown New Jersey
United States Virtua Health Mt. Holly New Jersey
United States Magnolia OB/GYN Research Center- Recruiting Myrtle Beach South Carolina
United States Jersey Shore University Medical Center Neptune New Jersey
United States Saint Peter's Hospital New Brunswick New Jersey
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Fair Oaks Women's Health Pasadena California
United States Precision Trials Phoenix Arizona
United States William Beaumont Hospital Royal Oak Michigan
United States IGO Medical Group San Diego California
United States West Coast OBGYN San Diego California
United States Women's Health Care Research San Diego California
United States Virtua Health Sewell New Jersey
United States Visions Clinical Research Tuscon Tucson Arizona
United States Women's Clinical Research Vista California
United States Virtua Health Voorhees New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Sequenom, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ehrich M, Deciu C, Zwiefelhofer T, Tynan JA, Cagasan L, Tim R, Lu V, McCullough R, McCarthy E, Nygren AO, Dean J, Tang L, Hutchison D, Lu T, Wang H, Angkachatchai V, Oeth P, Cantor CR, Bombard A, van den Boom D. Noninvasive detection of fetal trisomy 21 by sequencing of DNA in maternal blood: a study in a clinical setting. Am J Obstet Gynecol. 2011 Mar;204(3):205.e1-11. doi: 10.1016/j.ajog.2010.12.060. Epub 2011 Feb 18. — View Citation

Palomaki GE, Deciu C, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study. Genet Med. 2012 Mar;14(3):296-305. doi: 10.1038/gim.2011.73. Epub 2012 Feb 2. — View Citation

Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Deciu C, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011 Nov;13(11):913-20. doi: 10.1097/GIM.0b013e3182368a0e. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Estimate the false positive rate of SEQureDx Trisomy 21 Test pregnancy outcome No
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