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Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02226315
Recruitment Status : Terminated (Slow enrollment of eligible subjects)
First Posted : August 27, 2014
Last Update Posted : September 17, 2015
Sponsor:
Collaborator:
Friends Research Institute, Inc.
Information provided by (Responsible Party):
Sequenom, Inc.

Tracking Information
First Submitted Date August 20, 2014
First Posted Date August 27, 2014
Last Update Posted Date September 17, 2015
Study Start Date August 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2014)
Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay [ Time Frame: Subjects contacted within 3 years after pregnancy is completed ]
Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient
Original Primary Outcome Measures Same as current
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 Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies
Official Title A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy
Brief Summary This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Some subjects will be asked to provide a buccal cell sample for sequencing.
Sampling Method Non-Probability Sample
Study Population Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).
Condition
  • Down Syndrome
  • Edwards Syndrome
  • Patau Syndrome
  • Turner Syndrome
Intervention Not Provided
Study Groups/Cohorts Multiple gestations
Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).
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 Terminated
Actual Enrollment
 (submitted: September 15, 2015)
50
Original Estimated Enrollment
 (submitted: August 25, 2014)
1000
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
  • Subject was 18 years of age or older at the time of NIPT;
  • Subject provides signed and dated informed consent in English;

Exclusion Criteria:

  • Subjects' treating physician is not located in the United States.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02226315
Other Study ID Numbers SQNM-T21-109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sequenom, Inc.
Study Sponsor Sequenom, Inc.
Collaborators Friends Research Institute, Inc.
Investigators
Principal Investigator: Richard Porreco, MD Presbyterian/St. Luke's Medical Center
PRS Account Sequenom, Inc.
Verification Date September 2015