Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02226315
Other study ID # SQNM-T21-109
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT04854122 - Blood Flow Regulation in Individuals With Down Syndrome - Training Study N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Recruiting NCT01950624 - DS-Connect {TM}: The Down Syndrome Registry
Completed NCT04751136 - the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome Phase 2
Completed NCT04767412 - Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial N/A
Completed NCT04536506 - Bobath and Vojta Therapy for DS N/A
Not yet recruiting NCT04037579 - Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
Completed NCT02882698 - Performance Analysis in Down Syndrome on Mobile Phone N/A
Completed NCT01791725 - A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia Phase 2
Unknown status NCT01975545 - Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21 Phase 2
Completed NCT01808508 - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome N/A
Terminated NCT00754013 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 Phase 3
Terminated NCT00754052 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 Phase 3
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Completed NCT01256112 - Parent Supported Weight Reduction in Down Syndrome N/A
Completed NCT01594346 - Multicenter Vitamin E Trial in Aging Persons With Down Syndrome Phase 3
Completed NCT05343468 - Life Skills Improved in Children With Down Syndrome After Using Assistive Technology N/A
Suspended NCT05755464 - Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
Recruiting NCT04022460 - Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Completed NCT04818437 - Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome N/A