Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

NCT02226315 | Terminated

• 1 other identifier: SQNM-T21-109
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Edwards Syndrome; Patau Syndrome; Turner Syndrome

Keywords

noninvasive prenatal testing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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;

You may not qualify if:

• Subjects' treating physician is not located in the United States.

Sponsors & Collaborators

• Sequenom, Inc.: lead
• Friends Research Institute, Inc.: collaborator

Study Sites (1)

Presbyterian/St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Some subjects will be asked to provide a buccal cell sample for sequencing.

MeSH Terms

Conditions

Down Syndrome; Trisomy 18 Syndrome; Trisomy 13 Syndrome; Turner Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Sex Chromosome Disorders; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Richard Porreco, MD

  Presbyterian/St. Luke's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 27, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

US (1)