Breast Cancer
Conditions
Keywords
breast cancer, diagnosis, x-ray diffraction, synchrotron, hair
Brief summary
Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with breast cancer exhibits a difference in its molecular structure compared to that of an individual without breast cancer. This difference is visible in the X-ray diffraction pattern as a ring superimposed on the pattern for normal hair. The hypothesis of this study is that synchrotron x-ray diffraction can be used to differentiate hairs from women with medically diagnosed breast cancer from women not known to have the disease. To test this hypothesis, hair from 2000 women attending radiology clinics for mammography will be collected, analysed by x-ray diffraction and then analysed using Fermiscan proprietary image analysis software. The mammogram status of the subjects will be blinded from the diffraction analysts. Results will then be compared with mammography results to allow a direct comparison between the Fermiscan test and mammography in terms of specificity and sensitivity.
Interventions
PROCEDUREdiagnosis of breast cancer by x-ray diffraction of hair
Sponsors
Fermiscan Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
SINGLE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult women (aged \>20) who are undergoing mammography, and * Who are willing and able to provide informed consent; and * Who have usable scalp and/or pubic hair
Exclusion criteria
* Women who have dyed or permed their scalp hair within the previous 6 weeks and whose pubic hair is unavailable; * Women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and CIN \[cervical intra-epithelial neoplasia\]) within 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy (sensitivity and specificity) of the breast cancer test based on detection of an abnormal pattern of hair x-ray diffraction compared to the gold standard of mammography plus biopsy where indicated | — |
Secondary
| Measure | Time frame |
|---|---|
| The prevalence of a positive hair x-ray diffraction pattern and a negative mammogram; and the prevalence of a negative hair x-ray diffraction pattern and a positive mammogram; | — |
Countries
Australia
Contacts
Primary ContactPeter W French, BSc, MSc, PhD
Backup ContactGary Corino, BSc
Outcome results
None listed