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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnosis of breast cancer by x-ray diffraction of hair | Procedure |
| Measure | Description | 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 |
| Measure | Description | 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; |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter W French, BSc, MSc, PhD | Contact | +61292454460 | pfrench@fermiscan.com.au | |
| Gary Corino, BSc | Contact | +61292454460 | gcorino@fermiscan.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Phillip Yuile, MBBS, FRACR | Radiation Oncology Associates, Sydney, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bankstown Diagnostic Imaging Centre | Recruiting | Sydney | New South Wales | 2200 | Australia | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16876335 | Background | James VJ. A place for fiber diffraction in the detection of breast cancer? Cancer Detect Prev. 2006;30(3):233-8. doi: 10.1016/j.cdp.2006.04.001. Epub 2006 Jul 28. | |
| 15645416 | Background | James V, Corino G, Robertson T, Dutton N, Halas D, Boyd A, Bentel J, Papadimitriou J. Early diagnosis of breast cancer by hair diffraction. Int J Cancer. 2005 May 10;114(6):969-72. doi: 10.1002/ijc.20824. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Campbelltown Ultrascan Radiology |
| Recruiting |
| Sydney |
| New South Wales |
| Australia |
| Diagnostic Imaging Centre, St George Private Hospital | Recruiting | Sydney | New South Wales | Australia |
| Liverpool Ultrascan Radiology | Recruiting | Sydney | New South Wales | Australia |
| Penrith Imaging | Recruiting | Sydney | New South Wales | Australia |
| 12529353 | Background | James V. False-positive results in studies of changes in fiber diffraction of hair from patients with breast cancer may not be false. J Natl Cancer Inst. 2003 Jan 15;95(2):170-1. doi: 10.1093/jnci/95.2.170. No abstract available. |
| 11390537 | Background | Meyer P, James VJ. Experimental confirmation of a distinctive diffraction pattern in hair from women with breast cancer. J Natl Cancer Inst. 2001 Jun 6;93(11):873-5. doi: 10.1093/jnci/93.11.873. No abstract available. |
| 10078527 | Background | James V, Kearsley J, Irving T, Amemiya Y, Cookson D. Using hair to screen for breast cancer. Nature. 1999 Mar 4;398(6722):33-4. doi: 10.1038/17949. No abstract available. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |