Use of Hair to Diagnose the Presence of Breast Cancer

Phase 1

• Conditions: Breast Cancer

• Registration Number: NCT00419900
• Lead Sponsor: Fermiscan Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Status Verified: 2007-01
• Study First Submitted: 2007-01-07
• Study First Submitted QC: 2007-01-07
• Last Update Submitted: 2007-01-07
• Study First Posted: 2007-01-09
• Last Update Posted: 2007-01-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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;

Trial Locations

Locations (5)

Bankstown Diagnostic Imaging Centre; 🇦🇺 Sydney, New South Wales, Australia

Campbelltown Ultrascan Radiology; 🇦🇺 Sydney, New South Wales, Australia

Diagnostic Imaging Centre, St George Private Hospital; 🇦🇺 Sydney, New South Wales, Australia

Penrith Imaging; 🇦🇺 Sydney, New South Wales, Australia

Liverpool Ultrascan Radiology; 🇦🇺 Sydney, New South Wales, Australia