A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood (ZORAGEN)
Recruitment status was Recruiting
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.
|Official Title:||A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood|
- 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.
- 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.
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.
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||July 2013|
It is considered that 20 women with a pregnancy affected by Down's Syndrome (DS), and ~600 normal controls, will be required to be included to ensure sufficient samples for analysis to develop and perfect the diagnostic test. The annual incidence of Down's Syndrome in Oxford is approximately 12/year. The 'pick-up' rate of screening tests is 70-80%. Therefore, 20 true DS cases are likely within the proposed study timescale, making allowances for the cases that will inevitably be missed by screening and non-participation in the study. Patients will be followed up for the period of 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472523
|Oxford Radcliffe Hospital||Recruiting|
|Oxford, United Kingdom, OX39DU|
|Contact: Warris Bokhari, MBBS BSc. email@example.com|
|Principal Investigator: Paul Chamberlain, MBBS|
|Principal Investigator:||Paul Chamberlain, MBBS||National Health Service, United Kingdom|