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
  Purpose

A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.


Condition
Aneuploidy

Study Type: Observational
Official Title: A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood

Resource links provided by NLM:


Further study details as provided by Loxbridge Research LLP:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 600
Study Start Date: April 2007
Estimated Study Completion Date: July 2013
Groups/Cohorts
Controls
Trisomy 21/Aneuploidy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Mothers attending clinic for routine screening. Followed up at around 1 years duration.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472523

Locations
United Kingdom
Oxford Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX39DU
Contact: Warris Bokhari, MBBS BSc.       warris.bokhari@loxres.com   
Principal Investigator: Paul Chamberlain, MBBS         
Sponsors and Collaborators
Loxbridge Research LLP
Investigators
Principal Investigator: Paul Chamberlain, MBBS National Health Service, United Kingdom
  More Information

No publications provided

Responsible Party: Loxbridge Research LLP
ClinicalTrials.gov Identifier: NCT01472523     History of Changes
Other Study ID Numbers: ZOR07H0607101
Study First Received: October 11, 2011
Last Updated: November 15, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014