Down Syndrome Clinical Trial
— CHARMM-APOfficial title:
Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies
NCT number | NCT01052688 |
Other study ID # | SQNM T21-305 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2009 |
Est. completion date | August 31, 2021 |
Verified date | April 2020 |
Source | Sequenom, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.
Status | Completed |
Enrollment | 150 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Spectrum Health | Grand Rapids | Michigan |
United States | Fetal Diagnostic Institute of the Pacific | Honolulu | Hawaii |
United States | Perinatal Care Associates | Phoenix | Arizona |
United States | St. Joseph's Hospital and medical Center | Phoenix | Arizona |
United States | Women and Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | IGO | San Diego | California |
United States | San Diego Perinatal Center | San Diego | California |
United States | Sharp Grossmount | San Diego | California |
United States | Women's Healthcare at Frost Street | San Diego | California |
United States | Reiter, Hill, Johnson and Nevin | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Sequenom, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NIPD result compared to standard test results | Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result. | baseline |
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