Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000194460
Ethics application status
Approved
Date submitted
29/03/2007
Date registered
4/04/2007
Date last updated
4/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of Diffraction Patterns of Hair Fibres from Breast Cancer Patients using Synchrotron-Generated X-Ray
Scientific title
To Determine the Accuracy of Assessment of Hair Fibres from Breast Cancer Patients using Synchrotron-Generated X-Ray Diffraction
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ductal Carcinoma In-situ (DCIS) 1712 0
Early Breast Cancer (EBC) 1713 0
Metastatic Breast Cancer (MBC) 1714 0
Condition category
Condition code
Cancer 1805 1805 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants at the time of enrolment will be asked to provide a sample of hair (approx. 10 hairs) cut from the back of their head and/or pubic region. A nurse will collect the hair using a sample holding card. The samples will then be sent to a synchrotoron for X-ray diffraction analysis.
The samples will be tested in batches when the synchrotron is available, each sample will be tested once, unless the result is inconclusive.
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2525 0
To determine the accuracy of the x-ray diffraction test for breast cancer using hair.
Timepoint [1] 2525 0
The samples will be sent for testing once each group (DCIS, EBC and MBC) is completed (20 samples each).
Secondary outcome [1] 4370 0
There are no secondary objectives
Timepoint [1] 4370 0

Eligibility
Key inclusion criteria
Adult women can participate if they are willing and able to provide informed consent and have usable scalp and/or pubic hair. Women must have a diagnosis of DCIS, EBC or MBC.
Minimum age
20 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women are excluded if they have dyed or permed their scalp hair with the last six weeks and whose pubic hair is unavailable or women with a history of other cancers with the last five years.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1959 0
Commercial sector/Industry
Name [1] 1959 0
Fermiscan
Country [1] 1959 0
Primary sponsor type
Commercial sector/Industry
Name
Fermiscan
Address
Country
Australia
Secondary sponsor category [1] 1769 0
None
Name [1] 1769 0
Nil
Address [1] 1769 0
Country [1] 1769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3655 0
Royal Prince Alfred Hospital-Sydney South West Area Health Service Ethics Review Committee(RPAH Zone)
Ethics committee address [1] 3655 0
Ethics committee country [1] 3655 0
Australia
Date submitted for ethics approval [1] 3655 0
Approval date [1] 3655 0
14/02/2007
Ethics approval number [1] 3655 0
X07-0035

Summary
Brief summary
Examination of diffraction pattern in hair fibres from patients with breast cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27781 0
Address 27781 0
Country 27781 0
Phone 27781 0
Fax 27781 0
Email 27781 0
Contact person for public queries
Name 10867 0
Jane Beith
Address 10867 0
Dept Medical Oncology
RPAH
Missenden Road
Camperdown NSW 2050
Country 10867 0
Australia
Phone 10867 0
61 2 9515 8304
Fax 10867 0
61 2 9519 1546
Email 10867 0
[email protected]
Contact person for scientific queries
Name 1795 0
Jane Beith
Address 1795 0
Dept Medical Oncology
RPAH
Missenden Road
Camperdown NSW 2050
Country 1795 0
Australia
Phone 1795 0
61 2 9515 8304
Fax 1795 0
Email 1795 0
[email protected]

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.