Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

NCT ID: NCT02226315

Last Updated: 2015-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Down Syndrome Edwards Syndrome Patau Syndrome Turner Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Multiple gestations

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Friends Research Institute, Inc.

OTHER

Sponsor Role collaborator

Sequenom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Porreco, MD

Role: PRINCIPAL_INVESTIGATOR

Presbyterian/St. Luke's Medical Center

Locations

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Presbyterian/St. Luke's Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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SQNM-T21-109

Identifier Type: -

Identifier Source: org_study_id

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