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
Sponsor:
Information provided by (Responsible Party):
Loxbridge Research LLP
ClinicalTrials.gov Identifier:
NCT01472523
First received: October 11, 2011
Last updated: November 15, 2011
Last verified: November 2011

October 11, 2011
November 15, 2011
April 2007
Not Provided
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: 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.
Same as current
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.

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.

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
Not Provided
  • Controls
  • Trisomy 21/Aneuploidy
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 2013
Not Provided

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
No
United Kingdom
 
NCT01472523
ZOR07H0607101
Yes
Loxbridge Research LLP
Loxbridge Research LLP
Not Provided
Principal Investigator: Paul Chamberlain, MBBS National Health Service, United Kingdom
Loxbridge Research LLP
November 2011

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