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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Premaitha Health
Sponsor:
Information provided by (Responsible Party):
Premaitha Health
ClinicalTrials.gov Identifier:
NCT01472523
First received: October 11, 2011
Last updated: September 9, 2016
Last verified: September 2016

October 11, 2011
September 9, 2016
April 2007
December 2018   (final data collection date for primary outcome measure)
Validation of method of novel analysis for Aneuploidy [ Time Frame: 2013 Approx ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01472523 on ClinicalTrials.gov Archive Site
Optimization of existing methods for maximising ffDNA [ Time Frame: up to July 2019 ] [ Designated as safety issue: No ]
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.
Optimization of existing methods for maximising ffDNA [ Time Frame: July 2013 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
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.
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.
Observational
Not Provided
Not Provided
Retention:   Samples With DNA
Description:

Maternal peripheral blood samples taken in EDTA with that required for existing analysis.

Approx 1ml of fluid from amniocentesis/chorionic villus sampling is taken additional. Patients will be followed up for 1 year after sample taken.

Probability Sample
Mothers attending clinic for routine screening. Followed up at around 1 years duration.
Aneuploidy, NIPT
Not Provided
  • Controls
  • Aneuploidy
    T13, 18, 21 and other chromosomal abnormalities yet to be determined
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
July 2019
December 2018   (final data collection date for primary outcome measure)

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
Female
16 Years and older   (Child, Adult, Senior)
No
Contact: Rosalyn Mazey, BSc(hons) 01616676865 ext 1037 rosalyn.mazey@premaitha.com
United Kingdom
 
NCT01472523
07H0607101
Yes
Not Provided
Not Provided
Premaitha Health
Premaitha Health
Not Provided
Principal Investigator: Brenda Kelly, MBBS National Health Service, United Kingdom
Premaitha Health
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP