Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

This study has been terminated.

(Slow enrollment of eligible subjects)

Sponsor:

Collaborator:

Friends Research Institute, Inc.

Information provided by (Responsible Party):

Sequenom, Inc.

ClinicalTrials.gov Identifier:

NCT02226315

First received: August 20, 2014

Last updated: September 15, 2015

Last verified: September 2015

History of Changes

Purpose

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
Down Syndrome Edwards Syndrome Patau Syndrome Turner Syndrome


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Down syndrome Turner syndrome trisomy 13 trisomy 18

Genetic and Rare Diseases Information Center resources: Trisomy 18 Trisomy 13 Turner Syndrome Gonadal Dysgenesis

U.S. FDA Resources

Further study details as provided by Sequenom, Inc.:

Primary Outcome Measures:

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.


Enrollment:	50
Study Start Date:	August 2014
Study Completion Date:	September 2015
Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


Responsible Party:	Sequenom, Inc.
ClinicalTrials.gov Identifier:	NCT02226315 History of Changes
Other Study ID Numbers:	SQNM-T21-109
Study First Received:	August 20, 2014
Last Updated:	September 15, 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

ClinicalTrials.gov processed this record on July 17, 2017

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