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Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

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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.

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.

Condition or disease
Down Syndrome Edwards Syndrome Patau Syndrome Turner Syndrome

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Group/Cohort
Multiple gestations
Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).



Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Some subjects will be asked to provide a buccal cell sample for sequencing.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226315


Locations
United States, Colorado
Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Sequenom, Inc.
Friends Research Institute, Inc.
Investigators
Principal Investigator: Richard Porreco, MD Presbyterian/St. Luke's Medical Center

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT02226315     History of Changes
Other Study ID Numbers: SQNM-T21-109
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

Keywords provided by Sequenom, Inc.:
noninvasive prenatal testing

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female