Use of Hair to Diagnose Breast Cancer

Study Overview
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Brief Summary
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Study FT3.6k-2006 is a single centre (the Mater Hospital, Sydney), blinded trial of a diagnostic test for breast cancer, with outcomes compared to the gold standard of screening mammogram followed by biopsy where required. This study aims to perform X-ray diffraction analysis of coded hair samples from women with a documented breast health status, to validate the findings of James et al (Nature 398: 33-4, 1999; Int J Cancer 114: 969-72, 2005) who showed that the presence of breast cancer could be detected using synchrotron-derived x-ray diffraction of human hair (scalp or pubic). The aim is also to characterise the sensitivity and specificity of the hair test in detecting breast cancer in a screening setting, and to determine the significance of a positive hair test and a negative mammogram.

Detailed Description
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The test has the potential to improve the diagnostic (and consequently therapeutic) paradigm for breast cancer. Women attending a radiology clinic in the Mater Hospital, Sydney, for a mammogram will be invited to participate in the study. A few hairs will be cut from their head or pubic region, put into a coded container and sent to the sponsor for analysis by synchrotron-x-ray diffraction. Although an imperfect standard for a variety of reasons, mammography is the standard screening assay, and confirmation of the pathology of the lesions found by mammography is carried out by biopsy. This will be the standard to which the hair test results will be compared. A negative mammogram will confirm a negative hair test, but a negative mammogram combined with a positive hair diffraction test will need a different approach. In the event of a positive hair test and a negative second read of the mammogram, the patient will be contacted by the referring practitioner. Patients in this category will be offered a breast MRI. A negative breast MRI under these circumstances will be classified as a true negative.

Official Title
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A Prospective Blinded Study to Evaluate and Characterise an Assay for the Diagnosis of Breast Cancer Using Synchrotron-Derived X-Ray Diffraction of Hair Fibres.

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: x-ray diffraction of human hair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women (aged >20) who are undergoing mammography at the Mater Hospital, Sydney, 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: x-ray diffraction of human hair|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the determination of the accuracy (sensitivity and specificity) of the x-ray diffraction test for breast cancer using hair. Sensitivity is defined as the proportion of all positive Fermiscan tests that are true positives. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, hair, fibre, synchrotron, x-ray diffraction