- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02226315
Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies
September 15, 2015 updated by: Sequenom, Inc.
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
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.
Study Overview
Status
Terminated
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80218
- Presbyterian/St. Luke's Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Subjects contacted within 3 years after pregnancy is completed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Porreco, MD, Presbyterian/St. Luke's Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
August 20, 2014
First Submitted That Met QC Criteria
August 25, 2014
First Posted (Estimate)
August 27, 2014
Study Record Updates
Last Update Posted (Estimate)
September 17, 2015
Last Update Submitted That Met QC Criteria
September 15, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Endocrine System Diseases
- Disease
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Intellectual Disability
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Abnormalities, Multiple
- Chromosome Disorders
- Sex Chromosome Disorders
- Sex Chromosome Disorders of Sex Development
- Gonadal Dysgenesis
- Syndrome
- Down Syndrome
- Turner Syndrome
- Trisomy 13 Syndrome
- Trisomy 18 Syndrome
Other Study ID Numbers
- SQNM-T21-109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Down Syndrome
-
Rachel G. Greenberg, MD, MB, MHSEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsNot yet recruitingHyperactivity in Children With Down Syndrome | Impulsivity in Children With Down SyndromeUnited States
-
Riphah International UniversityCompletedDown S SyndromePakistan
-
Hoffmann-La RocheCompletedHealthy Volunteer, Down SyndromeUnited Kingdom
-
Cairo UniversityCompleted
-
Institute of Child HealthCompleted
-
Vanderbilt University Medical CenterNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingSpeech Intelligibility Intervention in Down SyndromeUnited States
-
Marmara UniversityCompletedStair up and Down, Amputation | Amputation,Stair up and DownTurkey
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMyeloid Proliferations Associated With Down SyndromeUnited States, Canada, Australia, Puerto Rico
-
Eastern Mediterranean UniversityCompletedDown Syndrome, Trisomy 21Cyprus
-
Institut Jerome LejeuneFondation Jérôme LejeuneCompletedDown Syndrome With and Without Auto Immune AbnormalitiesFrance