A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood (IONA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01472523|
Recruitment Status : Recruiting
First Posted : November 16, 2011
Last Update Posted : January 18, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood|
|Study Start Date :||April 2007|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||July 2019|
T13, 18, 21 and other chromosomal abnormalities yet to be determined
- 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.
- 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.
Biospecimen Retention: Samples With DNA
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472523
|Contact: Victoria Hutchinson, BSc(hons)||firstname.lastname@example.org|
|Contact: Claire Threlfall||01616676865||Claire.Threlfall@premaitha.com|
|Manchester, United Kingdom, M156SZ|
|Contact: Victoria Hutchinson, BSc(hons) 01616676865 email@example.com|
|Contact: William Denman, MBBS 0016177630620 firstname.lastname@example.org|
|Principal Investigator: Brenda Kelly, MBBS|
|Principal Investigator:||Brenda Kelly, MBBS||National Health Service, United Kingdom|