Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Down Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02226315
• Other study ID #: SQNM-T21-109
• Status: Terminated
• Phase: N/A
• First received: August 20, 2014
• Last updated: September 15, 2015
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Down Syndrome
• Edwards Syndrome
• Gonadal Dysgenesis
• Patau Syndrome
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Locations

Country	Name	City	State
United States	Presbyterian/St. Luke's Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Sequenom, Inc.	Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay	Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient	Subjects contacted within 3 years after pregnancy is completed	No