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

Aneuploidy, NIPT Clinical Trial

— IONA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472523
• Other study ID #: 07H0607101
• Status: Completed
• Start date: April 2007
• Est. completion date: December 2019

Study information

• Verified date: June 2020
• Source: Premaitha Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1632
• Est. completion date: December 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Aneuploidy, NIPT

Locations

Country	Name	City	State
United Kingdom	Premaitha Health	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Premaitha Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2013 Approx
Secondary	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.	up to July 2019