A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood (ZORAGEN)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Loxbridge Research LLP.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Loxbridge Research LLP
First received: October 11, 2011
Last updated: November 15, 2011
Last verified: November 2011
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.
||A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
Primary Outcome Measures:
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Mothers attending clinic for routine screening. Followed up at around 1 years duration.
- 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.
- 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
- Young offenders
- Adults who are unable to consent for themselves
- Any person considered to have a particularly dependent relationship with investigators
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01472523
|Oxford Radcliffe Hospital
|Oxford, United Kingdom, OX39DU |
|Contact: Warris Bokhari, MBBS BSc. firstname.lastname@example.org |
|Principal Investigator: Paul Chamberlain, MBBS |
Loxbridge Research LLP
||Paul Chamberlain, MBBS
||National Health Service, United Kingdom
||Loxbridge Research LLP
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 11, 2011
||November 15, 2011
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2016