Use of Hair to Diagnose Breast Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of James et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects, specifically those suffering from breast cancer.

The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from patients with confirmed breast cancer from subjects without detectable breast cancer.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: Cutting scalp hair	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	240 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	Single
Primary Purpose:	Diagnostic
Official Title:	A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.
Study Start Date :	October 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female

Criteria

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 hair

Exclusion Criteria:

• 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Peter W French, BSc, MSc, PhD	+61292454460	pfrench@fermiscan.com.au

Locations

Australia, New South Wales
St George Private Hospital	Recruiting
Sydney, New South Wales, Australia, 2217
Principal Investigator: Ronald Shnier, MBBS, FRACR

Sponsors and Collaborators

Fermiscan Ltd

Investigators

Principal Investigator:	Ronald Shnier, MBBS, FRACR	Symbion Health
Study Director:	Gary Corino, BSc	Fermiscan Ltd

More Information

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Publications:

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.

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.

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.

James VJ. The traps and pitfalls inherent in the correlation of changes in the fibre diffraction pattern of hair with breast cancer. Phys Med Biol. 2003 Jan 21;48(2):L5-9; discussion L11-3.

Kimura M, Tanaka N, Kimura Y, Miyake K, Kitaura T, Fukuchi H. Pharmacokinetic interaction of zonisamide in rats. Effect of other antiepileptics on zonisamide. J Pharmacobiodyn. 1992 Nov;15(11):631-9.

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..

ClinicalTrials.gov Identifier:	NCT00390377 History of Changes
Other Study ID Numbers:	FT240-2006
First Posted:	October 19, 2006
Last Update Posted:	October 19, 2006
Last Verified:	October 2006

Keywords provided by Fermiscan Ltd:

x-ray diffraction; hair; breast cancer; synchrotron

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases