Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000460505
Ethics application status
Not required
Date submitted
19/10/2006
Date registered
2/11/2006
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prenatal diagnosis of Down's Syndrome using isolation of foetal cells from cervical mucous and peripheral blood during first trimester of pregnancy
Scientific title
Prenatal diagnosis of Down's Syndrome using isolation of foetal cells from cervical mucous and peripheral blood during first trimester of pregnancy in women
Universal Trial Number (UTN)
Trial acronym
NPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnant women 1435 0
Condition category
Condition code
Reproductive Health and Childbirth 1531 1531 0 0
Other reproductive health and childbirth disorders
Human Genetics and Inherited Disorders 1532 1532 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single peripheral blood sample obtained by venupuncture at 10-12 weeks gestation, immediately prior to CVS. A single cervical mucous sample obtained by aspiration catheter at 10-12 weeks gestation, immediately prior to CVS. The whole period of the study is 24 months.
Intervention code [1] 1414 0
Diagnosis / Prognosis
Comparator / control treatment
A control group undergoing prenatal testing (Chorionic Villous Sampling at 10-12 weeks) but not participating in blood or cervical mucous sampling.
Control group
Active

Outcomes
Primary outcome [1] 2115 0
Sensitivity of the assay to detect Down Syndrome is assessed within 24 hours after the samples have been obtained.
Timepoint [1] 2115 0
24 months
Secondary outcome [1] 3658 0
Miscarriage Rate
Timepoint [1] 3658 0
24 months

Eligibility
Key inclusion criteria
Pregnant women presenting for Chorionic Villous Sampling.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women not requiring an invasive test.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Genetic scientists (assessors) and Data Analyst will be blinded for comparison of study results and routine karyotyping
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 411 0
New Zealand
State/province [1] 411 0

Funding & Sponsors
Funding source category [1] 1670 0
Commercial sector/Industry
Name [1] 1670 0
Genetic Technologies Ltd
Country [1] 1670 0
Primary sponsor type
Commercial sector/Industry
Name
Genetic Technologies Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 1473 0
Commercial sector/Industry
Name [1] 1473 0
Genetic Technologies Ltd
Address [1] 1473 0
Country [1] 1473 0
Australia

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 3113 0
Monash Medical Centre
Ethics committee address [1] 3113 0
Ethics committee country [1] 3113 0
Australia
Date submitted for ethics approval [1] 3113 0
Approval date [1] 3113 0
Ethics approval number [1] 3113 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27348 0
Address 27348 0
Country 27348 0
Phone 27348 0
Fax 27348 0
Email 27348 0
Contact person for public queries
Name 10603 0
Dr Richard Allman
Address 10603 0
Genetic Technologies Ltd
60-66 Hanover Street
Fitzroy VIC 3065
Country 10603 0
Australia
Phone 10603 0
+61 3 84127005
Fax 10603 0
+61 3 94176863
Email 10603 0
[email protected]
Contact person for scientific queries
Name 1531 0
Dr Debbie Mantzaris
Address 1531 0
Genetic Technologies Ltd
60-66 Hanover Street
Fitzroy VIC 3065
Country 1531 0
Australia
Phone 1531 0
+61 3 84127012
Fax 1531 0
+61 3 94176863
Email 1531 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.