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Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies (CHARMM-AP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01052688
Recruitment Status : Recruiting
First Posted : January 20, 2010
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.

Tracking Information
First Submitted Date January 15, 2010
First Posted Date January 20, 2010
Last Update Posted Date April 7, 2020
Study Start Date November 2009
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2013)
NIPD result compared to standard test results [ Time Frame: baseline ]
Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies
Official Title Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma, white blood cells
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
Condition
  • Down Syndrome
  • Aneuploidy
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.
Study Groups/Cohorts Pregnant Women
Pregnant women who have been definitively diagnosed as carrying a fetus with aneuploidy.
Intervention: Other: Maternal blood draw of 30 to 50ml
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 20, 2014)
300
Original Estimated Enrollment
 (submitted: January 19, 2010)
90
Estimated Study Completion Date September 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01052688
Other Study ID Numbers SQNM T21-305
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Samples and data are used in research and development of a noninvasive prenatal test. However, sample data used in publications will be shared as per requirements of the journal.
Responsible Party Sequenom, Inc.
Study Sponsor Sequenom, Inc.
Collaborators Not Provided
Investigators
Study Director: Juan-Sebastian Saldivar, M.D. Sequenom, Inc.
PRS Account Sequenom, Inc.
Verification Date April 2020