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NCT01052688 Clinical Trial

Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

Down Syndrome Clinical Trial

— CHARMM-AP  

Official title:
Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date April 2020
Source Sequenom, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Sequenom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
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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