Use of Hair to Diagnose the Presence of Breast Cancer

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00419900
• Other study ID #: FER2k
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 7, 2007
• Last updated: January 7, 2007
• Start date: December 2006

Study information

• Verified date: January 2007
• Source: Fermiscan Ltd
• Contact: Peter W French, BSc, MSc, PhD
• Phone: +61292454460
• Email: pfrench[@]fermiscan.com.au
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• diagnosis of breast cancer by x-ray diffraction of hair

Locations

Country	Name	City	State
Australia	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	Liverpool Ultrascan Radiology	Sydney	New South Wales
Australia	Penrith Imaging	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Fermiscan Ltd

Country where clinical trial is conducted

Australia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Erratum in: J Natl Cancer Inst. 2003 Feb 19;95(4):334.. — View Citation

James VJ. A place for fiber diffraction in the detection of breast cancer? Cancer Detect Prev. 2006;30(3):233-8. Epub 2006 Jul 28. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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;