Aneuploidy, NIPTIONANCT01472523
A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
An observational study of Aneuploidy, NIPT, run by Premaitha Health at 1 site in United Kingdom.
Trial summary
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Aneuploidy, NIPT
- How many people
- 1,632 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2007to Dec 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mothers attending clinic for routine screening. Followed up at around 1 years duration.
Who may be able to join
- Patient/subject is willing and able to give informed consent for participation in the study.
- Female, aged 16 years or above.
- Currently pregnant at time of entry to the study.
- Pregnancy having been identified as 'high-risk' by screening test.
Who cannot join
- The patient/subject may not enter the study if ANY of the following apply:
- The participant herself has Down's Syndrome or other chromosomal abnormality.
- Children under 16
- Adults with learning disabilities
- Adults who are unconscious or very severely ill
- Adults who have a terminal illness
Show all 13Show fewer
- Adults in emergency situations
- Adults suffering from a mental illness
- Adults with dementia
- Prisoners
- Young offenders
- Adults who are unable to consent for themselves
- Any person considered to have a particularly dependent relationship with investigators
Trial locations and contacts
1 site in 1 country.
About this study
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.
Read the detailed description
A total of ~2000 participants have donated blood samples used for the development and validation of the IONA non-invasive prenatal screening test for Downs, Edwards and Patau syndrome. The IONA Test was CE marked Feb 2013. We are now recruiting a further 800 participants to provide blood samples to further develop and verify the test for other chromosomal abnormalities and to improve test efficiency.
- Conditions
- Aneuploidy, NIPT
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Not described | |
| Aneuploidy | T13, 18, 21 and other chromosomal abnormalities yet to be determined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of method of novel analysis for Aneuploidy
Analysis of maternal blood by a selective amplification of fetal DNA over maternal DNA within that sample. Patients to be followed up for 1 year.
Measured: 2013 Approx
Secondary outcomes (1)
Optimization of existing methods for maximising ffDNA
Use of novel methods either in conjugation with existing methods or as a substitute for steps in existing methodologies- currently undergoing laboratory development that could increase the titre of fetal DNA within a given sample. Patients will be followed up for 1 year.
Measured: up to July 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startApr 2007
- Primary completionFeb 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneuploidy, NIPTStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Premaitha Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brenda Kelly, MBBS, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472523
- Sponsor's protocol ID
- 07H0607101
- Acronym
- IONA
- Status last verified
- Jun 2020
- First submitted
- 11 Oct 2011
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
- ClinicalTrials.gov ID
- NCT01472523
- Acronym / sponsor ID
- IONA / 07H0607101
- Conditions
- Aneuploidy, NIPT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,632 participants (estimated)
- Lead sponsor
- Premaitha HealthIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Nov 2011 (estimated)
- 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.
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.
Detailed description
A total of ~2000 participants have donated blood samples used for the development and validation of the IONA non-invasive prenatal screening test for Downs, Edwards and Patau syndrome. The IONA Test was CE marked Feb 2013. We are now recruiting a further 800 participants to provide blood samples to further develop and verify the test for other chromosomal abnormalities and to improve test efficiency.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | – |
| Aneuploidy | – | –T13, 18, 21 and other chromosomal abnormalities yet to be determined |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers attending clinic for routine screening. Followed up at around 1 years duration.
Key inclusion criteria (4 listed)
- Patient/subject is willing and able to give informed consent for participation in the study.
- Female, aged 16 years or above.
- Currently pregnant at time of entry to the study.
- Pregnancy having been identified as 'high-risk' by screening test.
Key exclusion criteria (13 listed)
- The patient/subject may not enter the study if ANY of the following apply:
- The participant herself has Down's Syndrome or other chromosomal abnormality.
- Children under 16
- Adults with learning disabilities
- Adults who are unconscious or very severely ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of method of novel analysis for Aneuploidy
Time frame: 2013 Approx
Analysis of maternal blood by a selective amplification of fetal DNA over maternal DNA within that sample. Patients to be followed up for 1 year.
1 secondary outcome
Optimization of existing methods for maximising ffDNA
Time frame: up to July 2019
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.
Related trials for Aneuploidy, NIPT
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
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.
Brenda Kelly, 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?
An observational study of Aneuploidy, NIPT, 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 4 inclusion and 13 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?
Validation of method of novel analysis for Aneuploidy (time frame: 2013 Approx). 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.