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

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ClinicalTrials.gov Identifier: NCT03200041
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Premaitha Health

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Down Syndrome Patau Syndrome Edward's Syndrome Procedure: Blood sample Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
Study Start Date : February 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Low Risk
350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.
 Procedure: Blood sample
20 ml blood sample taken from vein in arm
High Risk
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
20 ml blood sample taken from vein in arm


Outcome Measures
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Primary Outcome Measures :
  1. Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome. [ Time Frame: 18 months ]
    IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200041


Contacts
Contact: Victoria Hutchinson, BSc(hons) 01616676865 victoria.hutchinson@premaitha.com
Contact: Claire Threlfall, BSc(hons 01616676865 Claire.Threlfall@premaitha.com

Locations
United Kingdom
Premaitha Health Recruiting
Manchester, United Kingdom, M15 6SZ
Contact: Victoria Hutchinson    0161 667 6865    victoria.hutchinson@premaitha.com   
Sponsors and Collaborators
Premaitha Health
Investigators
Principal Investigator: Asma Khalil, MBBS National Health Service, United Kingdom
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Premaitha Health
ClinicalTrials.gov Identifier: NCT03200041     History of Changes
Other Study ID Numbers: PMH/0915/01
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IONA Test results being given to patients

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn