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Completed

NCT Number: NCT01472523

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

A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.

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Key information

Conditions

Aneuploidy, NIPT Aneuploidy Chromosome Aberrations Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Premaitha Health

Manchester, M156SZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Optimization of existing methods for maximising ffDNA

    Time frame: up to July 2019

    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.

Sponsors and collaborators

Lead sponsor

Premaitha Health

Industry

Registry information

Acronym: IONA

Important dates

Study start
2007
Primary completion
2018
Study completion
2019
First posted
Nov 16, 2011
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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