Trial record 30 of 42 for:
Recruiting, Not yet recruiting, Available Studies | "Down Syndrome"
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies (TWIN)
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| ClinicalTrials.gov Identifier: NCT03200041 |
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Recruitment Status :
Recruiting
First Posted : June 27, 2017
Last Update Posted : January 18, 2018
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Sponsor:
Premaitha Health
Information provided by (Responsible Party):
Premaitha Health
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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 |
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 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
| Arm | Intervention/treatment |
|---|---|
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Low Risk
350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.
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Procedure: Blood sample
20 ml blood sample taken from vein in arm |
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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.
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Procedure: Blood sample
20 ml blood sample taken from vein in arm |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| 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
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 |
| 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:
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Down Syndrome Syndrome Disease Pathologic Processes Intellectual Disability Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |