A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood

NCT ID: NCT01472523

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1632 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Aneuploidy, NIPT

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Controls

No interventions assigned to this group

Aneuploidy

T13, 18, 21 and other chromosomal abnormalities yet to be determined

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Premaitha Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brenda Kelly, MBBS

Role: PRINCIPAL_INVESTIGATOR

National Health Service, United Kingdom

Locations

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Premaitha Health

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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07H0607101

Identifier Type: -

Identifier Source: org_study_id

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