Clinical Evaluation of the IONA Test for Non-invasive Pre... | NCT03200041

Studies
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies

NCT03200041

Sponsor

Premaitha Health

Status

Completed

Last Update Posted

Jun 11, 2020Actual

Enrollment

1,000Actual

Phase

Not Applicable

Conditions

Down Syndrome
Patau Syndrome
Edward's Syndrome

Interventions

Blood sample

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Apr 25, 2016

First Submission Date that Met QC Criteria

Jun 23, 2017

First Posted Date

Jun 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the performance of the IONA® test which is a non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in twin pregnancies, from a maternal blood sample.

Detailed Description

350 low risk and 150 high risk women with twin pregnancies will be recruited to produce a large cohort evaluation the use of the IONA test in twin pregnancies for Downs, Edwards and Patau syndrome. Reserve samples will also be used to further develop the test for other chromosomal abnormalities.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Risk	Other	350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.	Procedure: Blood sample
High Risk	Other	150 High Risk going onto invasive diagnostic procedure. The only intervention is a 20 ml blood sample will be taken from each participant.	Procedure: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Procedure	20 ml blood sample taken from vein in arm	High Risk Low Risk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.	IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently pregnant with twin foetuses at time of entry to study
Have had or are about to have a conventional screening test (combined/quad test, ultrasound scan or other NIPT)
If identified as high risk, intend to undergo prenatal invasive diagnosis and/or undergoing invasive prenatal therapy such as laser treatment for TTTS where a sample of amniotic fluid is taken for karyotyping.

Exclusion Criteria:

Participant herself has down syndrome or other chromosomal abnormality

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asma Khalil, MBBS	National Health Service, United Kingdom	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Premaitha Health		Manchester		M15 6SZ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IONA Test results being given to patients

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004314	Down Syndrome
D000073839	Trisomy 13 Syndrome
D000073842	Trisomy 18 Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided