Down SyndromeTWINNCT03200041
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
A study testing Blood sample in people with Down Syndrome and Patau Syndrome, run by Premaitha Health at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Patau Syndrome, Edward's Syndrome
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participant herself has down syndrome or other chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Down Syndrome, Patau Syndrome, Edward's Syndrome
- Being tested
- Blood sample
- Medical subject headings
- Down Syndrome, Trisomy 13 Syndrome, Trisomy 18 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
20 ml blood sample taken from vein in arm
| Study group | Role | What they receive |
|---|---|---|
| Low Risk | Other | 350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant. Receives: 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. Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startFeb 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premaitha Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asma Khalil, MBBS, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200041
- Sponsor's protocol ID
- PMH/0915/01
- Acronym
- TWIN
- Status last verified
- Jun 2020
- First submitted
- 25 Apr 2016
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: IONA Test results being given to patients
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
- ClinicalTrials.gov ID
- NCT03200041
- Acronym / sponsor ID
- TWIN / PMH/0915/01
- Conditions
- Down Syndrome, Patau Syndrome, Edward's Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Premaitha HealthIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk | Other | Procedure: Blood sample350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant. |
| High Risk | Other | Procedure: Blood sample150 High Risk going onto invasive diagnostic procedure. The only intervention is a 20 ml blood sample will be taken from each participant. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participant herself has down syndrome or other chromosomal abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample20 ml blood sample taken from vein in arm | Procedure or surgery | High Risk, Low Risk |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Yes. IONA Test results being given to patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Khalil, MBBS principal investigator
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Down Syndrome and Patau Syndrome, run by Premaitha Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.