Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000480684
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Microarray Evaluaton of Normal Breast Tissue to Identify Genetic Markers of Risk for Estrogen Receptor Positive Breast Cancer
Scientific title
Microarray Evaluaton of Normal Breast Tissue to Identify Genetic Markers of Risk for Estrogen Receptor Positive Breast Cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Breast Cancer 601 0
Condition category
Condition code
Cancer 674 674 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A translational study involving analysis of malignant and benign breast tissue taken from women undergoing definitive surgery for invasive breast cancer.
Intervention code [1] 623 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 814 0
To identify genetic markers of risk of breast cancer that distinguish between risk of Estrogen Receptor positive and Estrogen Receptor negative disease
Timepoint [1] 814 0
Secondary outcome [1] 1626 0
To validate the predictive value of the identified markers in a second group of patients.
Timepoint [1] 1626 0

Eligibility
Key inclusion criteria
1. Female, unilateral invasive breast cancer2. Normal contralateral mammogram3. No prior systemic therapy4. Informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 745 0
Self funded/Unfunded
Name [1] 745 0
Country [1] 745 0
Primary sponsor type
Government body
Name
SSWAHS
Address
Country
Australia
Secondary sponsor category [1] 617 0
None
Name [1] 617 0
NIL
Address [1] 617 0
Country [1] 617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1966 0
Sydney Cancer Centre - RPAH
Ethics committee address [1] 1966 0
Ethics committee country [1] 1966 0
Australia
Date submitted for ethics approval [1] 1966 0
Approval date [1] 1966 0
Ethics approval number [1] 1966 0

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

Contacts
Principal investigator
Name 35408 0
Address 35408 0
Country 35408 0
Phone 35408 0
Fax 35408 0
Email 35408 0
Contact person for public queries
Name 9812 0
Bronwyn Murray
Address 9812 0
Sydney Cancer Centre
Department Medical Oncology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 9812 0
Australia
Phone 9812 0
+61 2 95156216
Fax 9812 0
+61 2 95155063
Email 9812 0
bronwyn.murray@email.cs.nsw.gov.au
Contact person for scientific queries
Name 740 0
Dr Anne Hamilton
Address 740 0
Sydney Cancer Centre
Department Medical Oncology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 740 0
Australia
Phone 740 0
+61 2 95156012
Fax 740 0
Email 740 0
anne.hamilton@cs.nsw.gov.au

No information has been provided regarding IPD availability


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.